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.
7 linked reportsMalfunction 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 4.23 |
| 2019-02 | 0 | 2.79 |
| 2019-03 | 0 | 2.8 |
| 2019-04 | 0 | 2.98 |
| 2019-05 | 0 | 3.2 |
| 2019-06 | 0 | 2.94 |
| 2019-07 | 0 | 3.13 |
| 2019-08 | 0 | 3.06 |
| 2019-09 | 0 | 3.44 |
| 2019-10 | 0 | 3.03 |
| 2019-11 | 0 | 3.71 |
| 2019-12 | 0 | 3.65 |
| 2020-01 | 0 | 4 |
| 2020-02 | 0 | 3.39 |
| 2020-03 | 0 | 3.91 |
| 2020-04 | 0 | 5.12 |
| 2020-05 | 0 | 3.66 |
| 2020-06 | 0 | 3.25 |
| 2020-07 | 0 | 4.33 |
| 2020-08 | 0 | 3.84 |
| 2020-09 | 0 | 3.96 |
| 2020-10 | 0 | 4.2 |
| 2020-11 | 0 | 4.71 |
| 2020-12 | 0 | 4.79 |
| 2021-01 | 0 | 5.04 |
| 2021-02 | 0 | 4.31 |
| 2021-03 | 0 | 4.23 |
| 2021-04 | 0 | 4.36 |
| 2021-05 | 0 | 4.5 |
| 2021-06 | 0 | 3.89 |
| 2021-07 | 0 | 4.62 |
| 2021-08 | 0 | 4.14 |
| 2021-09 | 0 | 4.68 |
| 2021-10 | 0 | 4.31 |
| 2021-11 | 0 | 4.32 |
| 2021-12 | 0 | 4.68 |
| 2022-01 | 0 | 4.29 |
| 2022-02 | 0 | 3.95 |
| 2022-03 | 0 | 4.39 |
| 2022-04 | 0 | 4.3 |
| 2022-05 | 0 | 4.41 |
| 2022-06 | 0 | 3.8 |
| 2022-07 | 0 | 3.97 |
| 2022-08 | 0 | 5.43 |
| 2022-09 | 0 | 4.83 |
| 2022-10 | 0 | 4.67 |
| 2022-11 | 0 | 4.75 |
| 2022-12 | 0 | 5.29 |
| 2023-01 | 0 | 5.11 |
| 2023-02 | 0 | 5.21 |
| 2023-03 | 2 | 5.71 |
| 2023-04 | 0 | 5.68 |
| 2023-05 | 1 | 5.69 |
| 2023-06 | 0 | 6.17 |
| 2023-07 | 1 | 5.3 |
| 2023-08 | 0 | 5.79 |
| 2023-09 | 0 | 5.16 |
| 2023-10 | 0 | 5.38 |
| 2023-11 | 0 | 4.64 |
| 2023-12 | 0 | 5.98 |
| 2024-01 | 0 | 5.1 |
| 2024-02 | 0 | 5.72 |
| 2024-03 | 0 | 7.95 |
| 2024-04 | 0 | 12 |
| 2024-05 | 0 | 11.96 |
| 2024-06 | 0 | 12.99 |
| 2024-07 | 0 | 11.47 |
| 2024-08 | 0 | 7.32 |
| 2024-09 | 0 | 7.17 |
| 2024-10 | 0 | 5.21 |
| 2024-11 | 0 | 5.33 |
| 2024-12 | 0 | 4.98 |
| 2025-01 | 0 | 5.73 |
| 2025-02 | 0 | 4.62 |
| 2025-03 | 0 | 4.91 |
| 2025-04 | 0 | 5.44 |
| 2025-05 | 0 | 5.39 |
| 2025-06 | 0 | 5.39 |
| 2025-07 | 0 | 4.81 |
| 2025-08 | 0 | 4.89 |
| 2025-09 | 0 | 4.43 |
| 2025-10 | 0 | 4.65 |
| 2025-11 | 0 | 5.79 |
| 2025-12 | 0 | 6.04 |
| 2026-01 | 0 | 5.49 |
| 2026-02 | 0 | 6.01 |
| 2026-03 | 0 | 5.26 |
| 2026-04 | 0 | 5.32 |
| 2026-05 | 0 | 6.02 |
| 2026-06 | 0 | 6.2 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-04-13 | Z-1677-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery timeDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. | 805 units | clearance family |
| 2023-04-13 | Z-1680-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery timeDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. | 3328 units | code info di |
| 2023-04-13 | Z-1679-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery timeDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. | 2372 units | clearance family |
| 2023-04-13 | Z-1678-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery timeDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. | 540 units | clearance family |
| 2023-04-13 | Z-1681-2023 | Class II | Open, Classified | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery timeDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand. | 1125 units | clearance family |
| 2012-01-27 | Z-1166-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | — | clearance family | |
| 2012-01-27 | Z-1168-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | — | clearance family | |
| 2012-01-27 | Z-1169-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | — | clearance family | |
| 2012-01-27 | Z-1170-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | — | clearance family | |
| 2012-01-27 | Z-1171-2012 | Terminated | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | — | clearance family |
Showing 1–10 of 20
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-07-14 | 1221934-2023-02753 | Malfunction | Available | exact di |
| 2023-05-19 | 1221934-2023-02038 | Malfunction | Available | exact di |
| 2023-03-31 | 1221934-2023-01411 | Malfunction | Available | exact di |
| 2023-03-23 | 1221934-2023-01347 | Malfunction | Available | exact di |
| 2019-01-22 | 1221934-2018-52871 | Malfunction | Available | exact di |
| 2019-01-22 | 1221934-2018-52872 | Malfunction | Available | exact di |
| 2019-01-21 | 1221934-2018-52539 | Malfunction | Available | exact di |
Regulatory clearances
Manufacturer compliance record
None in the loaded window.
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