MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that during surgery the device had lost power.There was no harm and no delay.No patient consequences were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2018, it was reported that during surgery the device lost power.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Medicrea has previously repaired/evaluated electric dermatome serial number (b)(4) two times as documented.The last repair was november 21, 2016 where it was reported that the device required repair and the ball bearing, spring seal, needle bearing, semi-circle bearings, vespel sleeve bearings, motor, seal/strain relief and plug harness assembly were replaced.This is not a related issue.Product review of the electric dermatome by medicrea on june 11, 2018 revealed that the motor and plug harness assembly were corroded and the reciprocating arm and lever were worn.Prior to repair, the device operated below motor speed specifications but was within calibration and side to side specifications at all tested thickness settings.Repair of the electric dermatome was performed by medicrea on june 14, 2018 which included replacement of the ball bearing, spring seal, needle bearing, semi-circle bearings, vespel sleeve bearings, motor, plug harness assembly, seal/strain relief, lever, ball plunger and reciprocating arm.Electric dermatome, serial number 203762, was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review by medicrea it was noted that the motor and plug harness assembly were corroded.Prior to repair, the device operated below motor speed specifications.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by medicrea it was noted that the motor and plug harness assembly were corroded.Prior to repair, the device operated below motor speed specifications.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7655509
• MDR Text Key: 113008738
• Report Number: 0001526350-2018-00590
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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 Model Number: N/A
• Device Catalogue Number: 00882100100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1