MAUDE Adverse Event Report: ZIMMER SURGICAL 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 03/01/2014

Event Type  malfunction  

Event Description

It was reported that the air dermatome handpiece was cutting in and out during testing.The issue was noticed prior to the procedure and there was no patient injury associated with the report.An additional device was available onsite for use during the procedure and there was no surgical delay.

Manufacturer Narrative

The device was returned to the manufacturer for repair and evaluation.The service record indicates that the device was manufactured on 11/28/2006 and was last repaired on 8/6/2013 for a non-related issue.Evaluation of the device observed damage to the head, hose, control bar and width plates.It was also noted that the leading edge of the control bar was flush with the master blade.Additionally, the device operated with motor speed specifications.Prior to repair, the device was outside of calibration specifications and side to side specifications at the zero thickness setting.Repair of the device included replacement of the head, hose, control bar, width plates and standard repair parts.The customer's reported event was not reproduced during testing and, therefore, a cause cannot be determined.It should be noted that improper handling most likely caused the damge to the head, hose, control bar, width plates and lack of calibration at the zero thickness setting.The device was serviced and returned to the customer.

• 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: 3834706
• MDR Text Key: 4399398
• Report Number: 1526350-2014-00202
• 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: 03/03/2014

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: 03/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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