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

Model Number	N/A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Device product code: lry.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the punch locked and would not release causing small part of aorta to tear which was fixed with suture.This caused a delay in the surgery.
Event or Problem Description
It was further reported that this happened during the cut of the first hole.The punch did not complete the cut and locked which caused the surgeon to tear a hole.The patient has not required any further intervention.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported that the cutting punch jammed.A visual inspection was conducted on the returned punch.The punch shows signs of attempted use including what appears to be blood/ tissue on the device.An attempt was made to push the plunger.When pushed the device was frozen and the cutting tip could not be moved.When a second, harder attempt was made to free the device the cutting tip did loosen.Once free the device was able to be cycled open/ closed as designed.A measurement was taken on both the cutting tip as well as the die assembly.The tip is undersized and is nonconforming per the inspection criteria.A second measurement was made on the die.The die assembly is within specification.The complaint is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Because the product was used, measurement accuracy of returned device cannot be determined.As such, the out of spec measurements detailed will not require escalation.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 report is being submitted to update additional information in section a1, a2, a3, b4, b5, g3, g6, h2, h3, h4, h6 and h10.

• Brand Name: ROTATING SURGICAL PUNCH 4.0MM TAPERED TIP 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: 15459333
• Report Number: 0002242056-2022-00007
• Device Sequence Number: 6005454
• Product Code: LRY
• UDI-Device Identifier: 10841291105183
• UDI-Public: (01)10841291105183(17)20261201(10)04527
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 080-403
• Device Lot Number: 04527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Male