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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

(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 hand piece powered on but stopped during use, this happened before starting the surgery at the time of instruments preparation there was no delay or any consequences as a result of this malfunction.No impact to patient.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Conclusion summary: on december 9, 2018, it was reported that the handpiece was not working.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).One time as documented in the repair reports in livelink.The last repair was january 5, 2017 where it was reported that the handpiece stopped working while the nurse was checking it and the head, control bar, lever, missing screw and standard repair parts were replaced.This is not a related issue.Product review of the electric dermatome on february 7, 2019 revealed that the motor would not operate and the calibration was out of specifications at the zero thickness setting only.Repair of the electric dermatome was performed by zimmer biomet surgical on february 7, 2019 which included replacement of the motor, power cord, power switch and bearings.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 it was noted that the motor would not operate.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the motor would not operate.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.

Event Description

No additional event information was received.

• 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: 8196324
• MDR Text Key: 131403771
• Report Number: 0001526350-2018-01127
• 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: 03/21/2019

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: 62394010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1