MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER DERMATOME BLADE

Model Number 00-8800-000-10

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

While physician was harvesting skin graft, the dermatome blade did not take the skin graft evenly.Dermatome blade and dermatome handle sequestered.

• Brand Name: ZIMMER DERMATOME BLADE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 18676491
• MDR Text Key: 335143232
• Report Number: MW5151238
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-8800-000-10
• Device Lot Number: 66383995
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic