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

Catalog Number 00880100100

Device Problem Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported the device works sporadically and uneven.No adverse events were reported as a result of this malfunction.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, d10, e4, g4, g7, h2, h3, h4, h6, h8, h10.Reported issue: on (b)(6) 2020, it was reported that during surgery the device works sporadically and uneven.The customer returned an air dermatome device, serial number (b)(6), for evaluation.Dhr review: 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.Device evaluations results/investigation findings: product review of the air dermatome by zimmer biomet taiwan on february 14, 2020 revealed the motor would not run, and the depth bar had very large side play.Repair of the air dermatome was performed by zimmer biomet taiwan on (b)(6) 2020 which included replacement of the motor, bearing pack, o-ring, seal, reciprocating arm external e-ring, machined head, lever, ball plunger, and width plate screws.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: 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 would not run, and the depth bar had very large side play.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.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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: 9648241
• MDR Text Key: 195529914
• Report Number: 0001526350-2020-00119
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 60336921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1