MAUDE Adverse Event Report: ZIMMER SURGICAL ELECTRIC DERMATOME HANDPIECE

Catalog Number 00-8821-001-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Information (3190)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

It was reported that the zimmer electric dermatome was working intermittently and was laboring.No additional clinical information was received prior to this report.If additional information is received, a follow up medwatch will be submitted.

Manufacturer Narrative

The device was returned to the manufacturer for repair and evaluation.The service record indicates that the device was manufactured on 12/4/1998 and was repaired on 9/28/2012 for service and calibration.Evaluation of the device of the device observed the device ran erratic and there was damage to the control bar.Prior to repair, the device was outside calibration specification at the zero, 0.0100" and 0.0200" thickness settings.In post-repair, corrosion of the exterior motor casing was observed.The motor operated erratically, but was within motor voltage specification.Given the corrosion on the motor casing, it is likely that the interior of the motor was corroded as well, which likely caused the device to become erratic and could have caused intermittent operation; however, the customer's reported event of intermittent operation could not be reproduced.The cause of the corrosion was likely due to the entry of moisture within the handpiece.Improper handing related to cleaning or sterilization of the unit most likely allowed moisture to enter the handpiece.In addition, improper handling likely caused the lack of calibration of the device.No information was obtained regarding customer's cleaning or sterilization practices; however, improper sterilization could have caused the corrosion on the motor.The device was serviced and returned to the customer.

• Brand Name: ELECTRIC DERMATOME HANDPIECE
• Type of Device: ELECTRIC DERMATOME HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 3777927
• MDR Text Key: 15937968
• Report Number: 1526350-2014-00014
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-8821-001-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1998
• 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