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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing the mesher was not working.No patient involvement.Upon device evaluation it was noted that the comb on the device was noted to be damaged.Diligence is complete as no additional info was noted.
Additional Manufacturer Narrative
This incident is being recorded under (b)(4).Review of the most recent repair record identified the following related repair: mesher no working during the test due to damaged comb.All worn or damaged components were replaced.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.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 ; 5745260384
• MDR Report Key: 25316363
• Report Number: 0001526350-2026-00612
• Device Sequence Number: 12079100
• Product Code: FZW
• UDI-Device Identifier: 00889024375390
• UDI-Public: (01)00889024375390(11)190923(10)64520255
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 64520255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• 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: 05/27/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown