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

Lot Number 65972712

Patient Problem Insufficient Information (4580)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

Dermatome did not take a clean piece of skin.Burn team decided to switch out the blade with a new one.No issues or complaints after with the new blade.Charge nurse on duty notified.

• Brand Name: ZIMMER DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 17691104
• MDR Text Key: 322887104
• Report Number: MW5145188
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 65972712
• 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 Age: 23 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White