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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon removed the cap and pressed the punch prior to putting the instrument into the surgical site.The small piece of material came out before the punch was used with the patient.
Additional Manufacturer Narrative
Zimmer biomet complaint # (b)(4).G2: foreign source: united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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.A visual inspection was conducted on the returned product.The punch itself was not returned.What was returned was a single piece of debris that was reported to have come out of the punch.The debris was returned without the original packaging and placed inside of the vial.The debris is being sent out for analysis to determine the composition.The analysis showed that following results.The ftir spectrum of the side 1 of the small piece of the unknown material matched the ftir spectra of tygon tubing.The ftir spectrum of the side 2 of the small piece of the unknown material matched the ftir spectra of tygon tubing.From the overlay spectra, the ftir spectrum of the side 1 of the small piece of the unknown material is identical to the ftir spectrum of the side 2 of the small piece of the unknown material.Since the product was opened it cannot be determined where the piece of tygon tubing came from.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.The reported event is confirmed, based on the returned piece of debris.

• 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: 18131633
• Report Number: 0002242056-2023-00028
• Device Sequence Number: 7752750
• Product Code: LRY
• UDI-Device Identifier: 10841291105169
• UDI-Public: (01)10841291105169(10)05726(17)270601
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 05726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2022
• 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
• Patient Sex: Unknown