Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
18 linked reports Injury 16Malfunction 2
5 11 16 22 2019-01: 0 reports for this device; peer average 2.7/device 2019-02: 0 reports for this device; peer average 2.25/device 2019-03: 0 reports for this device; peer average 2.48/device 2019-04: 0 reports for this device; peer average 2.92/device 2019-05: 0 reports for this device; peer average 2.5/device 2019-06: 0 reports for this device; peer average 2.25/device 2019-07: 0 reports for this device; peer average 2.93/device 2019-08: 0 reports for this device; peer average 2.76/device 2019-09: 0 reports for this device; peer average 2.73/device 2019-10: 0 reports for this device; peer average 2.55/device 2019-11: 0 reports for this device; peer average 3.41/device 2019-12: 0 reports for this device; peer average 3.71/device 2020-01: 0 reports for this device; peer average 3.63/device 2020-02: 0 reports for this device; peer average 2.63/device 2020-03: 0 reports for this device; peer average 3.53/device 2020-04: 0 reports for this device; peer average 3.61/device 2020-05: 0 reports for this device; peer average 2.72/device 2020-06: 0 reports for this device; peer average 2.81/device 2020-07: 0 reports for this device; peer average 3.67/device 2020-08: 0 reports for this device; peer average 3.46/device 2020-09: 0 reports for this device; peer average 3.19/device 2020-10: 0 reports for this device; peer average 3.42/device 2020-11: 0 reports for this device; peer average 3.88/device 2020-12: 0 reports for this device; peer average 3.64/device 2021-01: 0 reports for this device; peer average 3.27/device 2021-02: 0 reports for this device; peer average 3.81/device 2021-03: 0 reports for this device; peer average 3.82/device 2021-04: 0 reports for this device; peer average 4.17/device 2021-05: 0 reports for this device; peer average 3.54/device 2021-06: 0 reports for this device; peer average 3.19/device 2021-07: 0 reports for this device; peer average 3.85/device 2021-08: 0 reports for this device; peer average 3.19/device 2021-09: 0 reports for this device; peer average 3.8/device 2021-10: 0 reports for this device; peer average 3.96/device 2021-11: 0 reports for this device; peer average 3.69/device 2021-12: 0 reports for this device; peer average 4.07/device 2022-01: 0 reports for this device; peer average 4.06/device 2022-02: 0 reports for this device; peer average 3.84/device 2022-03: 0 reports for this device; peer average 3.39/device 2022-04: 2 reports for this device; peer average 2.78/device 2022-05: 0 reports for this device; peer average 4.05/device 2022-06: 0 reports for this device; peer average 2.99/device 2022-07: 0 reports for this device; peer average 3.11/device 2022-08: 0 reports for this device; peer average 4.22/device 2022-09: 0 reports for this device; peer average 3.75/device 2022-10: 0 reports for this device; peer average 4.28/device 2022-11: 0 reports for this device; peer average 5.11/device 2022-12: 0 reports for this device; peer average 6.48/device 2023-01: 0 reports for this device; peer average 5.6/device 2023-02: 0 reports for this device; peer average 5.68/device 2023-03: 0 reports for this device; peer average 6.57/device 2023-04: 0 reports for this device; peer average 5.32/device 2023-05: 0 reports for this device; peer average 6.36/device 2023-06: 0 reports for this device; peer average 6.96/device 2023-07: 0 reports for this device; peer average 6.39/device 2023-08: 0 reports for this device; peer average 7.04/device 2023-09: 2 reports for this device; peer average 5.22/device 2023-10: 0 reports for this device; peer average 6.67/device 2023-11: 0 reports for this device; peer average 3.71/device 2023-12: 0 reports for this device; peer average 6.06/device 2024-01: 0 reports for this device; peer average 4.89/device 2024-02: 0 reports for this device; peer average 5.84/device 2024-03: 0 reports for this device; peer average 12.62/device 2024-04: 0 reports for this device; peer average 17.46/device 2024-05: 0 reports for this device; peer average 20.88/device 2024-06: 0 reports for this device; peer average 21.68/device 2024-07: 0 reports for this device; peer average 19.97/device 2024-08: 0 reports for this device; peer average 9.99/device 2024-09: 0 reports for this device; peer average 8.5/device 2024-10: 0 reports for this device; peer average 6.57/device 2024-11: 0 reports for this device; peer average 5.72/device 2024-12: 0 reports for this device; peer average 5.3/device 2025-01: 0 reports for this device; peer average 4.35/device 2025-02: 0 reports for this device; peer average 3.94/device 2025-03: 0 reports for this device; peer average 3.8/device 2025-04: 0 reports for this device; peer average 4.5/device 2025-05: 14 reports for this device; peer average 4.94/device 2025-06: 0 reports for this device; peer average 4.44/device 2025-07: 0 reports for this device; peer average 3.69/device 2025-08: 0 reports for this device; peer average 3.73/device 2025-09: 0 reports for this device; peer average 3.5/device 2025-10: 0 reports for this device; peer average 4.13/device 2025-11: 0 reports for this device; peer average 5.56/device 2025-12: 0 reports for this device; peer average 4.55/device 2026-01: 0 reports for this device; peer average 4.23/device 2026-02: 0 reports for this device; peer average 5.67/device 2026-03: 0 reports for this device; peer average 4.25/device 2026-04: 0 reports for this device; peer average 4.09/device 2026-05: 0 reports for this device; peer average 4.92/device 2026-06: 0 reports for this device; peer average 4.6/device 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 Monthly adverse-event reports for this device versus the product-code average. Month This device (reports) Product-code average (reports per device) 2019-01 0 2.7 2019-02 0 2.25 2019-03 0 2.48 2019-04 0 2.92 2019-05 0 2.5 2019-06 0 2.25 2019-07 0 2.93 2019-08 0 2.76 2019-09 0 2.73 2019-10 0 2.55 2019-11 0 3.41 2019-12 0 3.71 2020-01 0 3.63 2020-02 0 2.63 2020-03 0 3.53 2020-04 0 3.61 2020-05 0 2.72 2020-06 0 2.81 2020-07 0 3.67 2020-08 0 3.46 2020-09 0 3.19 2020-10 0 3.42 2020-11 0 3.88 2020-12 0 3.64 2021-01 0 3.27 2021-02 0 3.81 2021-03 0 3.82 2021-04 0 4.17 2021-05 0 3.54 2021-06 0 3.19 2021-07 0 3.85 2021-08 0 3.19 2021-09 0 3.8 2021-10 0 3.96 2021-11 0 3.69 2021-12 0 4.07 2022-01 0 4.06 2022-02 0 3.84 2022-03 0 3.39 2022-04 2 2.78 2022-05 0 4.05 2022-06 0 2.99 2022-07 0 3.11 2022-08 0 4.22 2022-09 0 3.75 2022-10 0 4.28 2022-11 0 5.11 2022-12 0 6.48 2023-01 0 5.6 2023-02 0 5.68 2023-03 0 6.57 2023-04 0 5.32 2023-05 0 6.36 2023-06 0 6.96 2023-07 0 6.39 2023-08 0 7.04 2023-09 2 5.22 2023-10 0 6.67 2023-11 0 3.71 2023-12 0 6.06 2024-01 0 4.89 2024-02 0 5.84 2024-03 0 12.62 2024-04 0 17.46 2024-05 0 20.88 2024-06 0 21.68 2024-07 0 19.97 2024-08 0 9.99 2024-09 0 8.5 2024-10 0 6.57 2024-11 0 5.72 2024-12 0 5.3 2025-01 0 4.35 2025-02 0 3.94 2025-03 0 3.8 2025-04 0 4.5 2025-05 14 4.94 2025-06 0 4.44 2025-07 0 3.69 2025-08 0 3.73 2025-09 0 3.5 2025-10 0 4.13 2025-11 0 5.56 2025-12 0 4.55 2026-01 0 4.23 2026-02 0 5.67 2026-03 0 4.25 2026-04 0 4.09 2026-05 0 4.92 2026-06 0 4.6
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2025-05-12 1220246-2025-02008 Injury Available catalog number 2025-05-12 1220246-2025-02006 Injury Available catalog number 2025-05-12 1220246-2025-02014 Injury Available catalog number 2025-05-12 1220246-2025-02002 Injury Available catalog number 2025-05-12 1220246-2025-02009 Injury Available catalog number 2025-05-12 1220246-2025-02007 Injury Available catalog number 2025-05-09 1220246-2025-01960 Injury Available catalog number 2023-09-13 1220246-2023-07866 Injury Available catalog number 2022-04-11 1220246-2022-04723 Malfunction Available catalog number
Showing the most recent 9 of 18 linked reports.
Manufacturer compliance record
Date Type Outcome Facility Citations 2025-01-13 VAI Voluntary action indicated Arthrex, Inc. 2 2025-01-13 VAI Voluntary action indicated Arthrex, Inc. 2 2023-05-05 VAI Voluntary action indicated Arthrex, Inc. 2 2023-05-05 VAI Voluntary action indicated Arthrex, Inc. 2 2016-08-25 VAI Voluntary action indicated Arthrex, Inc. 1 2016-08-25 VAI Voluntary action indicated Arthrex, Inc. 1 2013-09-27 NAI No action indicated Arthrex Gmbh 0 2013-09-27 NAI No action indicated Arthrex Gmbh 0 2013-09-25 NAI No action indicated ARTHREX GMBH 0 2013-09-25 NAI No action indicated ARTHREX GMBH 0
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