MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER AIR DERMATOME

Lot Number 112500

Device Problem Use of Device Problem (1670)

Patient Problem Tissue Damage (2104)

Event Date 01/09/2020

Event Type  Injury  

Event Description

The zimmer dermatome blade was put on upside down (it can be placed in the device either way) and a full thickness skin graft was taken, instead of the intended split thickness.Concern that blade can go on either way.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER BIOMET ; 345 east main street; warsaw IN 46580
• MDR Report Key: 9785291
• MDR Text Key: 182298223
• Report Number: 9785291
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 112500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2020
• Device Age: 4 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR