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 works intermittently.No add'l clinical info was received prior to this report.

Manufacturer Narrative

The device was returned to the mfr; however, the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

• 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: 3894279
• MDR Text Key: 4539984
• Report Number: 1526350-2014-00092
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/16/2014

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: 01/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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