MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00770100000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being recorded as an initial/final under (b)(4).G2: foreign - event occurred in united kingdom.Complaint can be confirmed through the returned product analysis.The ratchet was found to fail testing.Review of the most recent repair record determined the unit was found to have a damaged comb and bottom roll and passed the sample mesh graft.The ratchet was found to fail testing.The comb, bottom roll, ratchet gear, screw, and viler ss ball detens were replaced and resolved the reported issue.The root cause of the reported issue is attributed to a design issue.The reported event is confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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
It was reported the device, sent in for preventive maintenance, and was found to have a fault at a repair center.The unit inspection during investigation identified a damaged comb.There was no patient involvement.Diligence is complete.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Common Device Name: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24698545
• Report Number: 0001526350-2026-00323
• Device Sequence Number: 10046638
• Product Code: FZW
• UDI-Device Identifier: 00889024375390
• UDI-Public: (01)00889024375390(11)190404(10)64371003
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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
• Device Catalogue Number: 00770100000
• Device Lot Number: 64371003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown