MAUDE Adverse Event Report: Zimmer Surgical, Inc. Zimmer Skin Graft Mesher; Expander, Surgical, Skin Graft

Catalog Number	00770100000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during kit inspection the ratchet handle is faulty.There was no patient involvement.Upon evaluation it was identified that the comb was damaged.Due diligence is complete.
Additional Manufacturer Narrative
This incident is being recorded under (b)(4) as an initial final report.G2: foreign - event occurred in united kingdom.E1: telephone- (b)(6).Complaint can be confirmed through the returned product analysis.Review of the most recent repair record determined that the damaged comb.Few components were damaged and worn out.Discolored bottom roll.All the damaged or worn-out components were replaced to resolve the reported issue.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as component failure as the device exhibits wear and tear from repeated use.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.

• 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 ; +1(574)526-0384
• MDR Report Key: 50672604
• Report Number: 0001526350-2026-01102
• Device Sequence Number: 10174701
• Product Code: FZW
• UDI-Device Identifier: 00889024375390
• UDI-Public: (01)00889024375390(11)170929(10)63791003
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 63791003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2026
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown