MAUDE Adverse Event Report: ZIMMER DERMATOME

Device Problems Calibration Error (1078); Failure to Align (2522); Failure to Cut (2587)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

When an electric zimmer dermatome was employed for use to provide soft tissue coverage of patient's right hand and forearm it was found to be malfunctioning.The malfunction was described as a "calibration error" meaning the blade on the device was too prominent.Despite multiple attempts by the surgeon to adjust the machine, the device was not able to cut a smooth sample for grafting.There were 3 transverse -8cm lacerations at the donor site (right anterior thigh) which required suturing.The 12 x 8cm graft was shredded making it unusable.A second graft site (right posterior thigh) was utilized with another zimmer dermatome and the procedure was completed successfully.Reason for use: skin grafting.

• Brand Name: DERMATOME
• Type of Device: NI
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 4531496
• MDR Text Key: 18032185
• Report Number: MW5040794
• Device Sequence Number: 1
• Product Code: GFD
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR