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 01/01/2014

Event Type  malfunction  

Event Description

It was reported that the zimmer electric dermatome operates intermittently.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 04/05/2011 and was last repaired on 06/05/2013 for a non-related issue.Evaluation of the device observed that the power switch was recessed into the electric dermatome and the device did not operate.The power switch was observed to be separated in half at the upper and lower casings.Prior to repair, the electric dermatome was within calibration specifications at all tested thickness settings.In post-repair, the motor operated within motor voltage specifications.Customer returned a power supply.There was no visible issues with the device and met all functional specifications prior to repair.While the switch casing was observed to be nicked and bent, the timing of the event is unk as the switch could have been damaged by the customer or from disassembly during the repair process.It is known, however, that the switch was separated at the upper and lower casing prior to repair, since it is physically impossible for the switch to be recessed otherwise.Known information and investigation findings support the cause of the customer's reported event to be improper handling, as excessive downward force upon the switch button likely caused the switch casings to separate.Improper handling was most likely the cause for the damaged switch, which most likely caused the customer's reported event.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 ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3752934
• MDR Text Key: 19297124
• Report Number: 1526350-2014-00065
• 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: Consumer
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/06/2014

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: 01/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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
• Treatment: 00-8821-006-00, SN# (B)(4).; ELECTRIC DERMATOME POWER SUPPLY,