MAUDE Adverse Event Report: ZIMMER SURGICAL ELECTRIC DERMATOME KIT

Catalog Number 00-8821-000-00

Device Problems Calibration Error (1078); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 01/07/2015

Event Type  Injury  

Event Description

It was reported that the zimmer electric dermatome was used to provide soft tissue coverage of the patients right forearm but was found to be malfunctioning.The malfunction was described as a "calibration error" which described 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 three transverse -8cm lacerations at the donor site (right anterior thigh) which required suturing.The 12 8 cm 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.

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Manufacturer Narrative

This is a duplicate medwatch report of submitted reports #1526350-2015-00016 and #1523650-2015-00019.The device was manufactured on 5/24/2013 and was previously returned for repair on 1/8/2015 for a non-related issue.The electric dermatome device, serial number (b)(4), was not returned to zimmer surgical for evaluation and repair.Per the clinical follow-up, it was stated, "the device is no longer in rotation and they have began using new devices.The device will not be returned for investigation." the customer's reported event could not be confirmed and a cause could not be determined.

• Brand Name: ELECTRIC DERMATOME KIT
• Type of Device: ELECTRIC DERMATOME KIT
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4890738
• MDR Text Key: 6072631
• Report Number: 1526350-2015-00112
• 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: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-8821-000-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1