MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has returned the product to zimmer biomet.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

Dermatome was not running stable and it was losing power when used.This occurred during inspection, outside of the operating room.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).On july 25, 2018, it was reported that the device does not run stable.It was losing power when used.The customer returned an air 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.Medicrea has previously repaired/evaluated air dermatome serial number (b)(4) one time as documented in the vdoc service portal.The last repair was december 4, 2017 where it was reported that the device was calibrated incorrectly, it made a deep cut and the ball bearings, o-rings, spring seal, needle bearing, semi-circle bearing, vespel sleeve bearing, poppet housing, poppet spring, throttle hinge, throttle hinge gasket, seal screw, poppet, motor, motor sleeve, control bar, thickness control shaft and reciprocating arm were replaced.This is not a related issue.Product review of the air dermatome by medicrea on august 6, 2018 revealed that the entry calibration failed.The thickness control shaft did not conform to the input tests.The service technician also suggested to replace all faulty parts.Repair of the air dermatome was not performed by medicrea as the customer cancelled their request for service.The reported event was non-verifiable since it was not noted during the product review by medicrea if the device operated below motor speed specifications.However, none of the faulty components the service technician suggested to replace would have attributed to the air motor operating below specifications.The root cause of the reported event could not be specifically determined with the information that was provided.It was not noted during the product review by medicrea if the device operated below motor speed specifications.However, none of the faulty components the service technician suggested to replace would have attributed to the air motor operating below specifications.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, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7789283
• MDR Text Key: 117436323
• Report Number: 0001526350-2018-00799
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: 00880100100
• Device Lot Number: 63196888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1