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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during sterilization, the 3:1 roller had a nick on it.The unit wasn¿t used prior to sterilization, so damage must have happened during re-sterilization and not on a procedure or patient.There was no patient involvement.During device evaluation it was discovered that the cutter failed the test cut.Due diligence is complete, there is no further information available.
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 identified the following related repair: tech confirmed the cutter was damaged and found it failed the test cut.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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: 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: 22286605
• Report Number: 0001526350-2025-00775
• Device Sequence Number: 8876190
• Product Code: FZW
• UDI-Device Identifier: 00889024375468
• UDI-Public: (01)00889024375468(11)180117(10)63898285
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 63898285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• 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: 06/17/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2018
• 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