MAUDE Adverse Event Report: ZIMMER SURGICAL, INC ZIMMER BIOMET DERMATOME BLADE

Catalog Number 00-8800-000-10

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

Surgeon using dermatome blade from zimmer biomet and noticed that the skin graft harvest was unexpectedly non-uniform.The graft was successful nonetheless but the product needed to be voluntarily reported.We have since been notified by the manufacturer of a med device field safety notice on this device.

• Brand Name: ZIMMER BIOMET DERMATOME BLADE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC; dover OH 44622
• MDR Report Key: 17949571
• MDR Text Key: 326008291
• Report Number: MW5147007
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-8800-000-10
• Device Lot Number: 65647382
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White