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

Catalog Number 00882100100

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Once the investigation of the device is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that the device does not stay on.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).D4: udi #: (b)(4).Product review of the electric dermatome sn (b)(6) by flextronics on 7 april 2020 revealed that the motor speed was not stable, the unit was out of calibration, the insulation cable was damaged, and the needle bearing and screw were worn.Repair of the device was performed by flextronics on 7 april 2020 which included replacement of the following: motor, plug harness assembly, needle bearing, screw.Additional repair included re-calibration.The device, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested per zpo 5.7035.Electric dermatome sn (b)(6) has been previously repaired/evaluated one time as documented in the repair reports in livelink.The last repair was 24 january 2018 by medicrea where it was reported that bearings, motor, plug harness assembly, control bar, and screws were replaced.This is a related issue.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event is confirmed.

Event Description

The clinical engineering department has reported that the device does not work properly.The device was not staying on.The event happened before surgery intervention, so no harm to patient/operator.

• 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: 9465622
• MDR Text Key: 197755796
• Report Number: 0001526350-2019-01159
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 63314048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1