MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS AIR DERMATOME HANDPIECE

Catalog Number 00-8801-001-00

Device Problem Device Stops Intermittently (1599)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the air dermatome handpiece was not working.It was also mentioned that, the machine was working intermittently.There was no patient harm or delay reported.

Manufacturer Narrative

On may 31, 2012, us and (b)(6) customers were sent an urgent patient safety advisory informing of the need for proper care and preventative maintenance of their device information them of improperly maintaining instruments that may cause donor site injuries or results in damage to the graft.The device was returned to the manufacturer for repair and evaluation.The service record indicates that he device was manufactured on may 12, 1997 and was last repaired on may 20, 2004 for a non-related issue.Evaluation of the device observed the intermittent operation of the device.There was also damage to the head and control bar.Prior to repair, the device was within calibration specifications at all tested thickness settings.Repair of the device included replacement of the motor, head, control bar, housing and all standard repair parts.Post repair analysis revealed discoloration to the motor sleeve and the motor could not be separated from the motor sleeve.In addition, corrosion to the interior of the housing was observed.This device has not been returned to zimmer surgical for maintenance or repair in ten years; therefore, lack of preventative maintenance most likely caused the corrosion within the handpiece, which most likely caused the customer's reported event.The device was serviced and returned to the customer.

• Brand Name: AIR DERMATOME HANDPIECE
• Type of Device: AIR DERMATOME HANDPIECE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3894504
• MDR Text Key: 22141747
• Report Number: 1526350-2014-00325
• 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: 04/01/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: REF 61798
• Patient Sequence Number: 1