MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 6 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501400
Medical Device Problem Codes	Failure to Cut (2587); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Laceration(s) (1946); Skin Tears (2516)
Date of Event	10/02/2024
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.G2 country: switzerland.
Event or Problem Description
It was reported that during surgery, using meshgraft ii, the skin graft was partially completed.The quality of the graft was not good when it came out of the meshgraft.Thickness of the graft: 0.3mm.The medical professional indicated harm/injury to the patient.The graft was damaged when using the meshgraft, but the graft was used.An additional unplanned skin graft was necessary to complete the operation of an additional graft site.There was a surgical delay of about 1 hour, and the patient was under anesthesia during this time.There were no sutures needed.Due diligence is in process, no further information is available.
Event or Problem Description
There is no additional information regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, h6, and h11.No product was returned; the images provided confirm that the device did not cut properly.The reported event states that the single-use dermacarrier was reused, which is classified as an off-label use.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to off-label use.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.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h6, h10, and h11.No product was returned; the images provided confirm that the device did not cut properly.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is 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 is no additional information regarding the event.

• Brand Name: 6 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: 20547254
• Report Number: 0001526350-2024-01304
• Device Sequence Number: 7541377
• Product Code: FZW
• UDI-Device Identifier: 00889024372573
• UDI-Public: (01)00889024372573(17)250131(10)64633880
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: PREAMENDMENT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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: 00219501400
• Device Lot Number: 64633880
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 03/26/2025; 09/22/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 03/28/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DERMACARRIERPN: 00219501300SN: UNKNOWN.LN: 65935702; DERMACARRIERPN: 00219501400SN: UNKNOWN.LN: 65045172; MESHGRAFT IIPN: 00219500100SN: (B)(6).LN: UNK; MESHGRAFT IIPN: 00219500100SN: (B)(6).LN: UNK; MESHGRAFT IIPN: RK-0100-770-0NSN AND LN: UNKNOWN.; MESHGRAFT IIPN: RK-0100-770-0NSN AND LN: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male