MAUDE Adverse Event Report: Zimmer Surgical, Inc. Z.S.G.M. Cutter 2:1 Ratio; Expander, surgical, skin graft

Catalog Number	00770302000
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• Brand Name: Z.S.G.M. Cutter 2:1 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: 50860630
• Report Number: 0001526350-2026-01148
• Device Sequence Number: 9508798
• Product Code: FZW
• UDI-Device Identifier: 00889024375451
• UDI-Public: (01)00889024375451(11)220721(10)65571624
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 00770302000
• Device Lot Number: 65571624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2025
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown