MAUDE Adverse Event Report: Zimmer Surgical, Inc. 1.5 TO 1 DERMACARRIER; Expander, Surgical, Skin Graft

Catalog Number	00219501200
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: 1.5 TO 1 DERMACARRIER
• 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: 50117301
• Report Number: 0001526350-2026-00923
• Device Sequence Number: 10040473
• Product Code: FZW
• UDI-Device Identifier: 00889024378773
• UDI-Public: (01)00889024378773(17)280705(10)66130024
• Combination Product (Y/N): N
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 00219501200
• Device Lot Number: 66130024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown