MAUDE Adverse Event Report: Zimmer Surgical, Inc. Z.S.G.M. Cutter 1.5:1 Ratio; Expander, Surgical, Skin Graft

Catalog Number	00770301500
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that skingraft mesher doesn't make smooth holes for grafts.There is no information provided regarding the timing of the event or if there was any patient involvement/harm that may have occurred.During device evaluation, it was discovered that the cutter failed the sample mesh test.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information is available, we are unable to provide further information.
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Review of the most recent repair record determined the device failed the sample mesh test during evaluation.The cutter was damaged; however, the cutter is not repairable.The cutter was returned as is.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to component failure as the device exhibits wear and tear from repeated use.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.G2: foreign: finland.

• Brand Name: Z.S.G.M. Cutter 1.5:1 Ratio
• 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: 50869133
• Report Number: 0001526350-2026-01150
• Device Sequence Number: 9223543
• Product Code: FZW
• UDI-Device Identifier: 00889024375444
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: Preamendment
• 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): 09/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00770301500
• Device Lot Number: 64643571
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2026
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown