MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E MEDICAL / ROTATING SURGICAL PUNCHES RSP 4.0MM 6BOX ST; PUNCH, SURGICAL

Catalog Number	080-401
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiac surgery (cabg) procedure, a scrub nurse tested the rotating surgical punch during table setup, and several small, black-colored fragments of plastic fell out of the device.This issue was identified before patient use.The procedure was completed using an alternate device.No additional complications were reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in canada.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.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; g1; g3; g6; h1; h2; h3; h6.The reported event is unconfirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: d9; g3; h1; h2; h3; h6; h11.A visual inspection was conducted on the returned device.The product was received with the packaging opened.The product does not show any signs of use.Included in the shipment was a small piece of tape including a single black piece of debris.The product was returned with the original cap.The debris was sent out for ftir analysis.The analysis showed that the debris spectrum and the cap spectrum were most consistent with unknown material and pvc containing polymers.As the product was opened it cannot be determined where the debris came from.Root cause attributed to manufacturing packaging issue.A corrective action has been initiated to address the reported malfunction.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 RSP 4.0MM 6BOX ST
• 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: 21772842
• Report Number: 0002242056-2025-00005
• Device Sequence Number: 8073292
• Product Code: LRY
• UDI-Device Identifier: 10841291105169
• UDI-Public: (01)10841291105169(10)25008(17)290601
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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: Health Professional
• Device Catalogue Number: 080-401
• Device Lot Number: 25008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 09/25/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/19/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Patient Sex: Unknown