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

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

The dermatome did not move smoothly over skin.The area was prepped correctly, skin was positioned correctly.Dr began moving dermatome over the skin and it began missing and jumping causing the blade to chop at the skin in an irregular pattern.Dr tried another area and the same thing happened.Fda safety report id# (b)(4).

• Brand Name: BIOMET NITROUS DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 8927183
• MDR Text Key: 155556083
• Report Number: MW5089273
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 83