MAUDE Adverse Event Report: ZIMMER SURGICAL ZIMMER AIR DERMATOME II HANDPIECE

Catalog Number 00-8851-001-00

Device Problem Failure to Auto Stop (2938)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

It was reported that the zimmer air dermatome ii continues to run after grafting is stopped.No add'l clinical info was rec'd prior to this report.

Manufacturer Narrative

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

• Brand Name: ZIMMER AIR DERMATOME II HANDPIECE
• Type of Device: ZIMMER AIR DERMATOME II 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: 3695886
• MDR Text Key: 16087854
• Report Number: 1526350-2014-00037
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-8851-001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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