MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 1.5 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501200
Medical Device Problem Codes	Incorrect Measurement (1383); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
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.E1 telephone number: (b)(6).G2 country: sweden.
Event or Problem Description
It was reported that during surgery the plate that was used was a different size than what was indicated on the packaging.The indicated size on the package was 1.5:1 but it was a 3:1 ratio.There was a larger hole in the taken graft but the graft was utilized on the patient.The taken graft did not look good several days later as it was mushy and smelled bad.It was treated with saline-soaked compresses for one week with dressing changes.There was no delay in the procedure.Due diligence is complete and there is no additional information available.

• Brand Name: 1.5 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM)
• 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: 24421732
• Report Number: 0001526350-2026-00197
• Device Sequence Number: 10604958
• Product Code: FZW
• UDI-Device Identifier: 00889024372559
• UDI-Public: (01)00889024372559(17)300601(10)82330736
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00219501200
• Device Lot Number: 82330736
• Was Device Available for Evaluation?: No
• 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: 02/09/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown