MAUDE Adverse Event Report: ZIMMER SURGICAL AIR DERMATOME HANDPIECE

Catalog Number 00-8801-001-00

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 air dermatome works intermittently.No add'l clinical info was received prior to this report.If add'l info is received, a follow up medwatch will be submitted.

Manufacturer Narrative

Beginning (b)(6) 2012, us and (b)(6) customers were sent an urgent pt safety advisory informing them of the need for proper care and preventative maintenance of their zimmer air dermatome.Customers were informed that improperly maintained instruments may cause donor site injuries or result in damage to the graft.Customers were requested to contact zimmer to schedule maintenance for the device in accordance with the instructions for use.The device was returned to the mfr for repair and eval.The service record indicates that the device was manufactured on 08/15/1994 and has no repair history at zimmer surgical.Eval of the device observed nicks along the leading edge of the control bar and wear to the ears and leading edge of the head.It was also noted that this device had older style of reciprocating arm and thickness control lever.The master blade was flushed and the motor speed was within specs.It was observed that there was an air leakage at the connection between the hand piece housing and neck of the device.Prior to repair, the device was outside calibration spec on the left side at zero and 0.0200" thickness settings.Side to side calibration failed at all tested thickness settings.The customer's reported event could not be determined; however, lack of preventative maintenance could have caused the internal damage to the motor over time, potentially leading to intermittent failure.The cause of the damage to the head and lack of calibration is likely due to the user not maintaining the device per preventative maintenance and improper handling.

• Brand Name: AIR DERMATOME HANDPIECE
• Type of Device: AIR 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: 3894278
• MDR Text Key: 16860613
• Report Number: 1526350-2014-00091
• 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
• Remedial Action: Other
• 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: 00-8801-001-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2014
• 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?: Yes
• Date Device Manufactured: 08/15/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 61798
• Patient Sequence Number: 1