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	06/03/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during routine harvesting of a skin graft, the dermatome failed to excise a graft except only along one small edge of the dermatome blade.A repeat attempt proved the same results.The entire dermatome set (pressurized n2 tubing, dermatome head, blade, & guard) were changed to a new set and brought onto the field.A repeat attempt revealed the same results.Conferring with a partner attending in troubleshooting did not improve the problem.Finally, a new dermatome blade from a different lot number (#66646709) was used in the device and the device functioned appropriately.It was assumed that blades from lot#66609275 are defective though outwardly not appearing abnormal.All dermatome blades from that lot were taken out of service.There was a surgical delay of an unknown amount.There was no patient harm.Due diligence is in progress, 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 updated: a2, a3, a4, a%, a6, b4, b5, d2, d10, g1, g3, g6, h1, h2, and h11.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that during surgery, single use dermatome blade failed to perform as expected for treatment of a patient's full thickness burn.During routine harvesting of the skin graft, the zimmer air dermatome (pressurized nitrogen powered) failed to excise a graft except only along one small edge of the dermatome blade.A repeat attempt proved the same results.The entire dermatome set(pressurized nitrogen tubing, dermatome head, blade, & guard) was changed to a new set and brought onto the field.A repeat attempt with this new surgical instrument tray and new single use blade created the same results.Finally, a new dermatome blade from a different lot number was used in the device and the device functioned appropriately.The patient had a larger donor site scar resulting from the need for multiple attempts at donor site harvest which will result in a larger permanent scar from the donor site than would be expected for the size of the recipient site.No further intervention other than routine donor site care.The taken graft was damaged as multiple passes generated predominantly unusable skin grafts until they identified that the dermatome worked appropriately after switching to an unaffected lot.An additional unplanned skin graft was not needed in order to complete the surgery.The staff took about 20-30 minutes to identify the source of the problem and troubleshoot possibilities before being able to correct the issue and continue with the procedure.Due diligence is complete, there is no additional information available.
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, 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 cannot be 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: 22346587
• Report Number: 0001526350-2025-00815
• Device Sequence Number: 15596700
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)290213(10)66609275
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: 66609275
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 11/25/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/22/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: DERMATOME BLADE.00880000010.LN:66646709.; UNK DERMATOME SN: (B)(6).; UNK ZIMMER AIR DERMATOMESN: (B)(6).
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White