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

Model Number N/A

Device Problem Loss of Power (1475)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source - foreign - (b)(6).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.Not returning.

Event Description

It was reported that the headpiece of the unit was losing power.No adverse events were reported as a result of this malfunction.

Event Description

No additional information.

Manufacturer Narrative

This follow up report is being submitted to report additional information.On december 3, 2018, it was reported that the unit was losing power.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet australia has not previously repaired/evaluated air dermatome serial number (b)(4) as documented in the repair reports in livelink.Product review of the air dermatome by zimmer biomet australia on december 3, 2018 revealed that the head and depth bar had visible signs of wear.Product review of the air dermatome by zimmer biomet taiwan on march 27, 2019 revealed that the device did not operate when tested.Repair of the air dermatome was performed by zimmer biomet taiwan on march 29, 2019 which included replacement of the motor, machined head, bearings, o-ring, seal, reciprocating arm, external e-ring, lever, ball plunger and width plate 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 device did not operate when tested.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 did not operate when tested.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: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8200447
• MDR Text Key: 131725250
• Report Number: 0001526350-2018-01139
• 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: 04/16/2019

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 Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 2765200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1