MAUDE Adverse Event Report: ZIMMER ZIMMER AIR DERMATOME II

Model Number 00-8851-001/00

Device Problems Material Erosion (1214); Flaked (1246); Detachment of Device or Device Component (2907)

Patient Problems Erosion (1750); Impaired Healing (2378); Tissue Breakdown (2681)

Event Date 03/18/2015

Event Type  Injury  

Event Description

The pt is a (b)(6) female who sustained full thickness burns to her arm hand and foot from a grease fire.The pt underwent skin graft procedure on (b)(6) 2015.The surgeon reported that he was using the dermatome to harvest a third split-thickness skin graft from the left lateral thigh adjacent to the other two skin graft sites.It was set at 10th/1000 of an inch and had worked without complication on the first two passes.I checked that the guard was in the rails and dermatome depth adjustment was set correctly prior to the third pass.During the third pass, the beginning of the skin graft was taken at a normal depth.I noticed at mid-thigh the graft was lightly thicker.I stopped the dermatome and noted the depth to be at 18-20th/1000 of an inch.The problem appears to have come from the guard on the side opposite the depth adjustment gauge to have slid or popped out of the rail allowing a deeper skin graft harvest.We removed the dermatome from the field and everyone in the room was alerted to the problem.I placed epinephrine soaked telfa over the wound and divided the good portion of the graft from the deeper portion.The good portion was meshed in our usual fashion and used on the hand.

• Brand Name: ZIMMER AIR DERMATOME II
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER; warsaw IN
• MDR Report Key: 4707439
• MDR Text Key: 5652486
• Report Number: 4707439
• Device Sequence Number: 1
• Product Code: GFD
• 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: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-8851-001/00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2015
• Distributor Facility Aware Date: 03/18/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR