MAUDE Adverse Event Report: Zimmer Surgical, Inc. Zimmer Skin Graft Mesher; Expander, Surgical, Skin Graft

Catalog Number	00770100000
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction

• Brand Name: Zimmer Skin Graft Mesher
• 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: 50404866
• Report Number: 0001526350-2026-01022
• Device Sequence Number: 16074737
• Product Code: FQH
• UDI-Device Identifier: 00889024375390
• UDI-Public: (01)00889024375390(11)170921(10)63760528
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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
• Device Catalogue Number: 00770100000
• Device Lot Number: 63760528
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2017
• 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