MAUDE Adverse Event Report: ZIMMER SURGICAL INC. ZIMMER ELECTRIC DERMATOME; DERMATOME BLADE

Model Number REF 00-8821-001-00

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Tissue Breakdown (2681)

Event Date 05/09/2019

Event Type  Injury  

Event Description

Surgeon planned for one skin graft to be obtained from left thigh.First skin graft a little too thick and not enough for left arm wound.Zimmer dermatome set 1 used at setting 10 to obtain second skin graft; however, skin graft too thick (malfunction of zimmer dermatome set 001).Do you have a picture of the product? yes.Fda safety report id# (b)(4).

• Brand Name: ZIMMER ELECTRIC DERMATOME
• Type of Device: DERMATOME BLADE
• Manufacturer (Section D): ZIMMER SURGICAL INC. ; dover OH 44622
• MDR Report Key: 8611956
• MDR Text Key: 145228767
• Report Number: MW5086637
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 00-8821-001-00
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 67 YR