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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Electric dermatome was making noise and powering on and off intermittently.The event happened during testing.There was no harm delay reported with the event.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On june 11, 2018, it was reported that the device was making noise and powering on and off intermittently.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.Zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number (b)(4) two times as documented in the repair reports in livelink.The last repair was january 22, 2016 where it was reported that the device would not run and the power cord assembly, power switch, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, and o-ring were replaced.This is not a related issue.Product review of the electric dermatome on june 27, 2018 revealed that the calibration was out of specifications.The motor ran erratically so the motor speed could not be measured.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by zimmer biomet surgical on june 27, 2018 which included replacement of the power cord assembly, power switch, ball detent, thickness lever, bearings, seal and retaining ring, motor, o-ring, and calibration shaft.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event that the device was making noise was non-verifiable as no atypical noise was noted during the product review.The reported event that the device was powering on and off intermittently was confirmed since during the product review it was noted that the motor ran erratically.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review no atypical noise was noted however it was noted that the motor ran erratically.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.

• 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: 7633943
• MDR Text Key: 112600450
• Report Number: 0001526350-2018-00571
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

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
• Device Lot Number: 61968505
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• 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