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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to the manufacturer for evaluation and investigation is in process.Once the investigation is completed, a supplemental medwatch will be filed accordingly.

Event Description

The customer reports that the dermatome stopped during the graft take.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information in the following fields.(b)(4).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.Medicrea has previously repaired/evaluated electric dermatome serial number (b)(4) three times as documented in the repair reports in livelink.The last repair was (b)(6) 2018 where it was reported that the device needed repair and the bearings, spring seal, motor, thickness control shaft, seal, and strain relief, were replaced.This is not a related issue.Product review of the electric dermatome by medicrea on (b)(6) 2018 revealed that the calibration was out of specifications at the zero setting only.The motor did not run and the control bar was in the correct position.The motor was corroded and the thickness control shaft was out of specifications.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by medicrea on (b)(6) 2018 which included replacement of the bearings, spring seal, motor, and thickness control shaft.Electric dermatome, serial number (b)(4) was then tested and functioned properly.It was repaired, inspected and tested per zimmer biomet repair procedures.The reported event was confirmed since during the product review it was noted that motor did not run.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 motor did not run.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
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7922235
• MDR Text Key: 122197125
• Report Number: 0001526350-2018-00905
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 10/15/2018

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: 63278431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1