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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that electric dermatome had low power-not constant/skips.This was noted during testing.There was no patient involvement.No adverse events 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.The following sections were updated: b4, d4, g4, g7, h1, h2, h3, h4, h6, h10.Conclusion summary: on april 11, 2019, it was reported that the unit had low power-not constant/skips.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) nine times as documented in the repair reports in livelink.The last repair was august 16, 2018 where it was reported that the device was not working correctly and the power cord assembly, power switch, ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, o-ring, and calibration shaft were replaced.This is not a related issue.Product review of the electric dermatome was not performed as the device no longer able to be reviewed.The customer purchased a new device and did not wish to have this one repaired or returned.Repair of the electric dermatome was not performed.The reported event was non-verifiable since the device was not available for evaluation.The customer purchased a new device and did not wish to have this one repaired or returned.The root cause of the reported event could not be specifically determined with the information that was provided.The device was not available for evaluation.The customer purchased a new device and did not wish to have this one repaired or returned.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.Product is no longer able to inspect.

Event Description

No additional event information.

• 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: 8520189
• MDR Text Key: 142233786
• Report Number: 0001526350-2019-00251
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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: 60957920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1