MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00770301500
Medical Device Problem Codes	Failure to Cut (2587); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device's 1.0-1.5 cutter was not cutting skin and was stuck in the machine.The hospital was able to free the stuck cutter from the machine graft harvested and nurses and surgeon had issues with meshing multiple sheets of skin.Cutter was not uniformly cutting into the skin and was not cutting all the way through.Surgeon had to complete the meshing of the sheets of skin with a blade before being able to apply graft to patient.At the end of the surgery nursing staff unable to open the pins to remove the cutting insert.Mesher sent to mdrd with cutting tool still inside.There was no note of patient impact there was but there was a delay, the surgery took longer than expected approximate 30 minutes due to additional steps needed to cut into the grafts before applying to patient.There was no other gaft need it, surgeon used grafts already harvested but had to complete the meshing by hand.Due diligence is completed; no further information is available.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2 country: canada.

• Brand Name: Z.S.G.M. CUTTER 1.5:1 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: 24817867
• Report Number: 0001526350-2026-00409
• Device Sequence Number: 12298645
• Product Code: FZW
• UDI-Device Identifier: 00889024375444
• UDI-Public: (01)00889024375444(11)220418(10)65477830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: 65477830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 00770303000.CUTTER 3:1 RATIO.LOT: 1515210.
• Patient Sex: Unknown