MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER DERMATOME PNEUMATIC HAND HELD

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2023

Event Type  Injury  

Event Description

Dermatome device allowed for the improper insertion of the blade which led to a full thickness graft which was not useable and sutured back into place over the graft site followed by requiring a second graft site for a partial thickness graft.

• Brand Name: ZIMMER DERMATOME PNEUMATIC HAND HELD
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 16844419
• MDR Text Key: 314374875
• Report Number: MW5117157
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR