MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

The unit had loss of power.The event occurred during surgery, but there was no harm involved and there was a delay between 1-15 minutes.An alternate device was used to complete procedure.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

(b)(4).On november 9, 2018, it was reported that the unit had a loss of power.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/zimmer biomet australia has previously repaired/evaluated electric dermatome serial number (b)(4) six times as documented in the repair reports in livelink.The last repair was (b)(6) 2016 where it was reported that the device had no power and the motor, bearings, spring seal, external e-ring, setscrew, hand piece switch, insulator, and harness assembly plug were replaced.This is not a related issue.Product review of the electric dermatome by zimmer biomet taiwan on december 11, 2018 revealed that the motor speed was below specifications.The calibration was out of specifications at all settings and the control bar was in the correct position.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by zimmer biomet taiwan on (b)(6) 2018 which included replacement of the motor, hand piece switch, bearings, o-ring, seal, and reciprocating arm.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review by zimmer biomet taiwan it was noted that the device operated below motor speed specifications.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet taiwan it was noted that the device operated below motor speed specifications.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, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8090793
• MDR Text Key: 128270304
• Report Number: 0001526350-2018-01055
• 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: 03/04/2019

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: 60845662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 02/26/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1