MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME BLADES

Catalog Number	00880000010
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	Skin Tears (2516); Unspecified Tissue Injury (4559)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure that there was an uneven graft thickness.There is no harm or delay reported.Due diligence is in progress and no additional information is available till date.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.G2: foreign country - taiwan.
Event or Problem Description
It was reported during the procedure that there was an uneven graft thickness.Skin graft was damaged and unusable requiring a new graft to be harvested.No delay was noted.Diligence is complete.No further information is available.
Additional Manufacturer Narrative
Following sections were updated or corrected: b4, b5, b1, b2, d2, g1, g3, g6, h1, h2, h11.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 available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h7, and h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.An image of a skin graft was provided that showed an incomplete skin graft with a middle strip.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 device design and manufacturing process.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.

• Brand Name: DERMATOME BLADES
• Common Device Name: DERMATOME
• 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: 21918372
• Report Number: 0001526350-2025-00559
• Device Sequence Number: 15680381
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280213(10)65648460
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 00880000010
• Device Lot Number: 65648460
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 09/26/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/02/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ZFA 2023-00208
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK DERMATOME.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown