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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).The customer returned an air dermatome device for evaluation.Zimmer biomet surgical has not previously repaired/evaluated the air dermatome.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Initial qa inspection of the air dermatome revealed that the r.P.M.Was at the low end of the specification and ran erratically.Also the calibration was within specification and the control bar was in the correct position.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet surgical which included replacement of the thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, poppet assembly, and o-ring.The air dermatome was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the initial inspection it was noted that the motor speed operated at the low end of the specifications and ran erratically.While during the initial inspection it was noted that the motor speed operated at the low end of the specifications and ran erratically, it is unknown with the information that was provided how this occurred.Therefore, based on the information that was provided the root cause of the reported event could not be specifically determined.The air dermatome was repaired, tested and returned to the customer.

Event Description

It was reported the dermatome was losing power during the case.No adverse events have been reported as a result of the 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: 6719584
• MDR Text Key: 80259222
• Report Number: 0001526350-2017-00426
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2017

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: 63037218
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1