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

Model Number	N/A
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).A visual inspection was conducted on the returned punch.The punch was returned with original packaging, the packaging was opened and the punch shows light signs of use.When the plunger was pulled back on the punch the cutting tip full retracted into the punch body as designed.There were no signs of binding or manufacturing defects.When the plunger was released the punch returned to its original position as designed.The complaint cannot be recreated.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.This event was previously reported on mfr number 0001032347-2023-00143.
Event or Problem Description
It was reported by the rep that the punch did not make a clean cut and the surgeon had to do additional suturing to the site.Delay is thought to be 2 to 3 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.

• 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: 18833710
• Report Number: 0002242056-2024-00007
• Device Sequence Number: 20656561
• Product Code: LRY
• UDI-Device Identifier: 10841291105220
• UDI-Public: (01)10841291105220(10)08539(17)271201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 080-481
• Device Lot Number: 08539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown