MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP ); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00770303000
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cutter failed the sample mesh test during evaluation; damaged cutter; however, the repair was not completed because cutters are not repairable.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.
Event or Problem Description
It was reported that during surgery the graft got stuck.Part of the graft was able to be utilized to finish the case.There was a small delay in the procedure but there was no impact to the patient.An additional unplanned graft was not needed as only a small piece of the taken graft was not salvageable.During product evaluation it was found that the cutter failed the test cut.Due diligence is complete and there is no additional information available.

• Brand Name: Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP )
• 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: 23019695
• Report Number: 0001526350-2025-01195
• Device Sequence Number: 9824838
• Product Code: FZW
• UDI-Device Identifier: 00889024375468
• UDI-Public: (01)00889024375468(11)200821(10)64839807
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 00770303000
• Device Lot Number: 64839807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 0001526350-2025-00474
• Patient Sequence Number: 1
• Patient Sex: Unknown