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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).On (b)(6) 2018, it was reported that during surgery, device blade was loose.It was also reported that the device slowed down then stopped, and also the skin that was being cut off was too thin.The dermatome has been in circulation for a while and seemed to work ok prior to this incident.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.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was (b)(6) 2013 where it was reported that the device needed repair and the ball detent, damaged head, damaged control bar, thickness lever, reciprocating arm, bearings, throttle lever, motor, swivel, poppet assembly, o-ring, 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 (b)(4) on (b)(6) 2018 revealed that the motor speed was below specifications.The control bar was in the correct position and the calibration was out of specifications at all settings.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet (b)(4) on (b)(6) 2018 which included replacement of the motor, bearings, o-ring, seal, reciprocating arm, screws, 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 non-verifiable since during the product review by zimmer biomet surgical it was that the control bar was in the correct position and the customer did not return hose and width plates for evaluation.The root cause of the reported event could not be specifically determined with the information that was provided.Since during the product review that the control bar was in the correct position and the customer did not return hose and width plates for evaluation.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

It was reported that during surgery, device blade was loose.Upon follow up, it was also reported that the device slowed down then stopped, and also the skin that was being cut off was too thin.There was a delay of approximately 20 minutes under anesthesia.A davies dermatome was used to complete the procedure.No harm was reported.No adverse events were reported as a result of this malfunction.

• Brand Name: ZMR AIR DERMATOME HANDPIECE
• 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: 7886875
• MDR Text Key: 120701423
• Report Number: 0001526350-2018-00864
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PEXEMPT
• 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: 09/18/2018

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: 31957100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/1999
• 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