MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Catalog Number 00880100100

Device Problem Loss of Power (1475)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (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 the air dermatome stopped working during surgical procedure.There was a minimal delay of 0-15 minutes and an alternate device was used to complete the procedure.There was no harm to the patient/user.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-0453418.Conclusion summary: on (b)(6) 2018, it was reported that the equipment stopped working during surgical procedure.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The customer also returned a hose and 1 inch/ 2 inch/ 3 inch/ 4 inch width plates, 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 taiwan/zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(4) two times as documented in the repair reports in livelink.The last repair was (b)(6) 2017 where it was reported that the device needed repair with no reason given and the machined head, bearings, adjustment cam, vespel bearings, o-ring, poppet housing, spring seal, external e-ring, reciprocating arm, 1 inch, 2 inch, 3 inch, and 4 inch width plates were replaced.This is not a related issue.Product review of the air dermatome by zimmer biomet australia on (b)(6) 2018 revealed that the depth bar was loose was able to be moved from side to side and the head showed signs of wear.Product review of the air dermatome by zimmer biomet taiwan on (b)(6) 2018 revealed that the motor did not operate.The calibration was out of specifications at all settings and the control bar was in the correct position.Repair of the air dermatome was performed by zimmer biomet taiwan on (b)(6) 2018 which included replacement of the motor, machined head, bearings, o-ring, seal, reciprocating arm, external e-ring, hinge throttle gasket, lever die cast, ball plunger, and screws.Air 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 motor did not operate.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 motor did 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: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8132745
• MDR Text Key: 129476713
• Report Number: 0001526350-2018-01079
• 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: 02/06/2019

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: 00880100100
• Device Lot Number: 60951925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1