MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E MEDICAL / ROTATING SURGICAL PUNCHES; PUNCH, SURGICAL

Catalog Number	080-351
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hospital inventory clerk found unidentified objects in the packaging during their inspection process.There was no patient involvement or impact, as the objects were identified outside of a clinical setting.The correct surgical technique was used when inspecting the product packaging.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): associated product information: - 080-351 (20669) - 080-351 (10333) - 080-351 (13141) - 080-351 (22660) - 080-351 (22660) g2: foreign - the event occurred in taiwan (r.O.C.) the customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Attempts have been made to gather all product identification information, and no further information has been provided.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h3; h4; h6; h10.The reported event has been confirmed.A visual inspection was conducted on the returned product.The returned packed device was still sealed.Visual inspection of the packaging showed one particle exceeding the manufacturing specification near the pouch chevron.A review of the device history records identified no deviations or anomalies during manufacturing.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The root cause of the reported issue is attributed to a manufacturing packaging issue addressed in a previous corrective action.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: A&E MEDICAL / ROTATING SURGICAL PUNCHES
• Common Device Name: PUNCH, SURGICAL
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22011686
• Report Number: 0002242056-2025-00010
• Device Sequence Number: 18115994
• Product Code: LRY
• UDI-Device Identifier: 10841291105145
• UDI-Public: (01)10841291105145(10)20669(17)281201
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 080-351
• Device Lot Number: 20669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Patient Sex: Unknown