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

Catalog Number 00-8821-001-00

Device Problem Device Stops Intermittently (1599)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was initially reported that the electric dermatome handpiece started skipping in the middle of a surgery.Additional clinical follow up determined that there was patient involvement but no patient harm associated with the event.No alternate device was available for use so the surgery was postponed until an alternate device could be obtained.This was not an emergency surgery situation.

Manufacturer Narrative

The device was returned to the mfr for repair and eval.The service record indicates that the device was mfg on 12/13/2006 and was last repaired on (b)(6) 2014 for a non-related issue.Eval of the device observed that the device operated erratically but within speed specifications.The reciprocating arm was observed to contact the upper abnormal noise during operation when the device was held at a 30 to 45 degree angle; however, this likely would have little to no effect with a width plate and blade attached during use.The associated power supply did not exhibit any functional issues during testing.Prior to repair, the device was outside of calibration specifications on the left side.Repair of the device included replacement of the control bar and standard repair parts.The device was returned to the customer.The motor performed within electrical specifications.There was corrosion and discoloration to the motor casing.The cause of the reported issue was not reproduced during testing; however, the erratic operation of the device may have caused or contributed to the reported event.Given the corrosion and discoloration to the motor casing, the motor likely became internally damaged due to the entry of moisture, resulting in faulty behavior.Special care related to cleaning or sterilization should be taken by the customer to prevent the entry of moisture within the device.The device was serviced and returned to the customer.

• Brand Name: ELECTRIC DERMATOME HANDPIECE
• Type of Device: ELECTRIC 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: 4013955
• MDR Text Key: 4878592
• Report Number: 1526350-2014-00399
• 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: Health Professional
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/15/2014

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: 05/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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