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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On june 11, 2018, it was reported that the device stopped working in the middle of harvesting the skin graft.When surgeon tried to turn on the dermatome, the unit made small noise and then completely dead.On july 9, 2018, it was clarified that the issue occurred during surgery.There was no harm, injury or adverse events reported.There was a 16-30 minute delay.Another device was used to complete the surgery.The customer returned an electric dermatome device, serial (b)(4), for evaluation.The device history record (dhr) and previous repair report review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical/ (b)(4) has previously repaired/evaluated electric dermatome serial (b)(4) once as documented in the repair reports in livelink.The last repair was november 14, 2016 where it was reported that there was an oozing white thick substance and the power cord assembly, power switch, ball detent, thickness control lever, reciprocating arm, bearings, seal, retaining ring, motor and o-ring were replaced.This is not a related issue.Product review of the electric dermatome by zimmer biomet (b)(4) on july 9, 2018 revealed that the device would intermittently not operate.The motor was very slow to start up sometimes not starting.Repair of the electric dermatome was not performed by zimmer biomet (b)(4) sine at the time the investigation the customer has not made a decision on the report quote.The reported event was confirmed since during product review the device was erratic and the motor was slow to start up or sometimes it wouldn¿t start.The cause of the device not working was due to an erratic motor.The root cause of the device not working could not be determined with the provided information since it is unknown how the damage occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.No further conclusions can be drawn from the complaint history review that warrants further action.

Event Description

It was reported that dermatome stopped working in the middle of harvesting skin graft.When surgeon tried to turn on the dermatome, the unit made small noise and then it was completely dead.The surgeon completed the procedure with a manual humby knife.There was a 10 minute delay to retrieve a new device.No patient consequences were reported as a result of this malfunction.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7745249
• MDR Text Key: 116092391
• Report Number: 0001526350-2018-00596
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2018

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 Catalogue Number: 00882100100
• Device Lot Number: 63247422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1