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

Model Number N/A

Device Problems Failure to Cut (2587); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 12/26/2023

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during surgery while obtaining a skin graft, a large, deep cut to the patient right distal thigh occurred.The wound required closure.The drive pin of the dermatome did not allow for flush dermatome blade placement.There was an unknown amount of delay to the procedure.Diligence is in process.No additional information has been received.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, g3, g6, h2, h6, h10.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during surgery at the first attempt at taking donor skin graft that it was discovered the dermatome created a large, deep cut to the patient right distal thigh.Sutures were required to close the wound that was created, as it was through the dermis into the subcutaneous tissues.An additional skin graft was required from the patient.The drive pin did not allow for flush dermatome blade placement.An unknown amount of delay to procedure occurred.Diligence is complete.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: 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: 18553215
• MDR Text Key: 333370726
• Report Number: 0001526350-2024-00125
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DERMATOME BLADEPN 00880000010LN 66383989
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose