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

Catalog Number 00880100100

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).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.Product review of the air dermatome by flextronics on (b)(6) 2019 revealed that the needle bearing was damaged and the reciprocating arm was worn.The eccentric shaft and ball bearings were corroded and the device was outside calibration specifications.The control bar was not in the correct position and the motor was defective and did not operate within motor speed specifications.Repair of the air dermatome was performed by flextronics on (b)(6) 2019 which included replacement of the needle bearing, reciprocating arm, eccentric shaft, ball bearings and motor.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the needle bearing was damaged and the reciprocating arm was worn.The eccentric shaft and ball bearings were corroded and the device was outside calibration specifications.The control bar was not in the correct position and the motor was defective.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

It was reported that an air dermatome needed repair and recalibration.During investigation, it was revealed that the device was operating under motor speed specifications.No adverse events were reported as a result of this malfunction.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9340607
• MDR Text Key: 189624086
• Report Number: 0001526350-2019-01038
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: 60234629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1