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 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device stops under load.In preoperative testing procedures , the oscillating doesn't work at all.No patient involvement.There was no harm or delay.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

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/corrected: b4, b5, d4, d10, g4, g7, h2, h3, h4, h6, h10.Product review of the electric dermatome handpiece (00882100100) serial number (b)(6) by a zimmer biomet certified service repair site - flextronics on 23 july 2020 revealed that the unit was not working properly; would stop under load and the oscillation does not work at all.During investigation, it was determined that the motor was defective and corroded.Similarly, the unit needed a switch and cord update.It was uncovered during the investigation that the needle bears needed to be replaced.Repair of the device was performed by a zimmer biomet certified service repair site - flextronics on 23 july 2020 which included replacement of the following: plug harness assembly; motor d.C.; needle bearing; switch/handpiece ; additional repair included passing final testing and extensive quality protocol before being returned.The device, serial number (b)(6), was then tested and functioned properly.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• 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: 10240036
• MDR Text Key: 197811262
• Report Number: 0001526350-2020-00582
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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: 62088326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1