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

Catalog Number	00880000010
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: taiwan.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that during surgery the dermatome produced a skin graft with uneven thickness.It was reported that there was no harm to the patient or any surgical delay.No additional information available is indicated.Diligence is complete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b4; b5; d2b; d4; d9; g1; g3; g6; h1; h2; h3; h4; h5; h6; h11.Review of the returned blade found no visible bends or warps in the blade.The blade thickness measured 0.0135 inches which is out of specification.Inspection of the blade edge confirmed the edge itself was within specification.While the blade thickness is undersize by 0.0005¿, the blade mount that the blade is secured to gives the blade extra rigidity to reduce the ability of the blade to flex and would not contribute to an uneven graft thickness.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.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 regarding the event.

• 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: 21945580
• Report Number: 0001526350-2025-00594
• Device Sequence Number: 8553867
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)290207(10)66600196
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 00880000010
• Device Lot Number: 66600196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DERMATOME.PN UNKNOWN.SN UNKNOWN.
• Patient Sex: Unknown