A&E Medical / Rotating Surgical Punches · recalls, adverse events, clearances

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.

33 linked reportsMalfunction 29Injury 4

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	3
2019-02	0	3.4
2019-03	0	2
2019-04	0	2.56
2019-05	0	1.75
2019-06	0	2
2019-07	0	4.33
2019-08	0	1.5
2019-09	0	2.83
2019-10	0	1.67
2019-11	0	2
2019-12	0	2.5
2020-01	0	1
2020-02	0	1
2020-03	0	3.5
2020-05	2	1.33
2020-06	0	2
2020-07	2	2.44
2020-08	0	4
2020-09	0	2.25
2020-10	0	5.13
2020-11	0	2.5
2020-12	0	3
2021-01	0	2.67
2021-02	0	3.33
2021-03	0	5.11
2021-04	0	3
2021-05	0	2.5
2021-06	0	2
2021-07	0	1.75
2021-08	0	3.67
2021-09	0	1
2021-10	0	1.5
2021-11	1	2.25
2021-12	2	1.8
2022-01	0	2
2022-02	0	1
2022-03	0	1.5
2022-04	0	14.33
2022-05	0	1
2022-06	0	2.5
2022-07	0	4
2022-08	0	1.5
2022-09	0	4
2022-10	0	2
2022-11	0	3
2022-12	0	4.75
2023-01	0	1
2023-02	0	1
2023-03	1	1.5
2023-04	0	1
2023-05	0	1.5
2023-06	0	3.6
2023-07	1	1
2023-08	0	1
2023-09	0	1
2023-11	2	1.5
2023-12	2	1.67
2024-01	0	1
2024-02	0	1
2024-03	0	1
2024-04	1	1
2024-05	0	2.5
2024-06	2	1.75
2024-08	0	1
2024-10	0	1.4
2024-11	0	1
2024-12	0	1
2025-02	1	1
2025-03	1	1
2025-04	4	2.25
2025-05	0	7
2025-06	9	6
2025-08	0	2
2025-11	1	1
2025-12	1	1.33
2026-01	0	1
2026-02	0	1
2026-05	0	1.5
2026-06	0	1

This device (reports/month)Average device in LRY (reports/device/month)

Failure-mode summaryAI-generated

33 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-12-08	0002242056-2025-00044	Malfunction	Available	exact di
2025-11-26	0002242056-2025-00043	Malfunction	Available	exact di
2025-06-18	0002242056-2025-00032	Malfunction	Available	exact di
2025-06-18	0002242056-2025-00033	Malfunction	Available	exact di
2025-06-06	0002242056-2025-00031	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00029	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00028	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00026	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00030	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00025	Malfunction	Available	exact di
2025-06-04	0002242056-2025-00027	Malfunction	Available	exact di
2025-04-10	0002242056-2025-00007	Malfunction	Available	exact di
2025-04-04	0002242056-2025-00005	Malfunction	Available	exact di
2025-04-04	0002242056-2025-00004	Malfunction	Available	exact di
2025-04-04	0002242056-2025-00006	Malfunction	Available	exact di

Showing the most recent 30 of 33 linked reports.

Showing 1–15 of 30

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2011-05-17	NAI	No action indicated	A&E Medical Corp	0

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