MAUDE Adverse Event Report: ZIMMER SURGICAL ELECTRIC DERMATOME HANDPIECE

Catalog Number 00-8821-001-00

Device Problem Device Stops Intermittently (1599)

Patient Problem Tissue Damage (2104)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was initially reported that the device had intermittent power.The graft harvest was not acceptable and another site for an additional graft harvest was required.Additional clinical information determined that there was patient harm reported in the event as the first graft site attempt damaged the skin/tissue in that area and left the graft unavailable.An alternate power box was tried first, but the dermatome still did not seem to function correctly.At that time, the dermatome was replaced with another and the original one was pulled out of service.An additional graft site was required to complete the surgery and a delay of about 15-30 minutes occurred due to troubleshooting and replacement of the device.The patient was under anesthesia during the time of delay.No further information was available regarding the reported event or what may have contributed to the issue.

Manufacturer Narrative

The device was manufactured on 08/25/2009 and was previously repaired (b)(4) 2014 for a non-related issue.Investigation revealed damage to the head and control bar.Prior to repair, the device operated erratically.The device was outside calibration and side to side specifications at the zero thickness setting.Repair of the device included replacement of the head, control bar, control shaft and standard repair parts.Post repair analysis revealed corrosion to the motor.The motor operated within electrical specifications without a load.The reported event was likely due to the erratic operation within electrical specifications without a load.The reported event was most likely due to the erratic operation of the device, which was most likely due to the noted corrosion to the motor.Special care regarding cleaning and sterilization should be taken to prevent the entry and accumulation of moisture within the handpiece that could lead to corrosion and to the malfunction of internal components.The device was repaired 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: 4855501
• MDR Text Key: 5873748
• Report Number: 1526350-2015-00104
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-8821-001-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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