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

Event Type  malfunction  

Event Description

It was reported that the zimmer electric dermatome worked 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)(4) 2012, us and (b)(4) customers were sent an urgent pt safety advisory informing them of the need for proper care and preventative maintenance of their zimmer aire 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 indicated that device was manufactured on (b)(4) 2011 and was last repaired on (b)(4) 2012 for a lack of power issue.Eval of the device observed the device to operate very slowly with both the customer's and repair power supplies initially.The device then proceeded to operate normally on the customer's power supply.It was then observed that the device has been altered, as evidenced by the spliced wires within the device.Prior to repair, the device was outside calibration specs at all tested thickness settings.In post-repair, excessive corrosion of the exterior motor casing was observed.The customer's power supply showed no visible issues and the device met all functional specs during testing.Improper handling related to cleaning or sterilization of the unit most likely allowed moisture to enter the hand piece, corroding the motor over time and most likely causing the customer's reported event.Additionally, the alterations made to the electric dermatome likely contributed to the reported event.The device was serviced and returned to the customer.

• Brand Name: ELECTRIC DERMATOME HANDPIECE
• Type of Device: ELECTRIC 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: 3894255
• MDR Text Key: 4677935
• Report Number: 1526350-2014-00089
• 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: 00-8821-001-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2014
• 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: 07/16/2011
• 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
• Treatment: ZIMMER ELECTRIC DERMATOME POWER SUPPLY,; SN# (B)(4)