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

Model Number	N/A
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgical punches were not sharp enough when used on a 28 mm artificial blood vessel.There was no harm or delay in procedure.Another punch was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10 ¿ medical products.Item# 080-401, lot# 09419, rotating surgical punches 4.0mm 6box st.G2: foreign source: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the two returned punches.The punches were returned outside of the packaging and showed signs of attempted use including debris on the tip cutting surfaces.The plungers for both punches were pulled back and the cutting tip fully retracted into the punch body on both punches.The cutting action appears to be working as it should on both punches.The caps for the punches were fully seated when received.The caps were removed and re-installed and locked in place as designed.The complaint is unable to be confirmed.The sharpness of the blades is unable to be tested due to attempted product use.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that 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: ROTATING SURGICAL PUNCHES 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: 19519533
• Report Number: 0002242056-2024-00011
• Device Sequence Number: 8412698
• Product Code: LRY
• UDI-Device Identifier: 20841291105166
• UDI-Public: (01)20841291105166(10)09419(17)280101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: N/A
• Device Catalogue Number: 080-401
• Device Lot Number: 09419
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown