MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 3 TO 1 DERMACARRIER; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501300
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Graft failure (4905)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the tissue was stretched significantly less than 3:1, the tissue had to be discarded and a new one taken.An additional medical intervention was required.No delay occurred.Due diligence is complete as no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in austria.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d4, g3, g6, h2, h3, h4, h6 and h11.No product was returned or pictures provided; functional, visual, and/or dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There was no additional information associated with this event.

• Brand Name: 3 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 ; 5745260384
• MDR Report Key: 24168054
• Report Number: 0001526350-2026-00072
• Device Sequence Number: 9113089
• Product Code: FZW
• UDI-Device Identifier: 00889024372566
• UDI-Public: (01)00889024372566(17)261018(10)65292843
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 00219501300
• Device Lot Number: 65292843
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown