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

Catalog Number 00880100100

Device Problem Device Stops Intermittently (1599)

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

Event Date 12/15/2016

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.The customer also returned a hose and 1¿/2¿/3¿/4¿ width plates, for evaluation.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(4) fourteen times time as documented in the repair reports folder in livelink.The last repair was august 10, 2016, where it was reported that the device was being sent in for repair and the ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, poppet assembly, and o-ring were replaced.This is not a related issue.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report 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 calibration and rpm's were within specifications.The device didn't stall while running on initial test.There was no damage to device upon visual inspection but 3" width plate was damaged.The device was tested under the stroboscope it #929 with the qa test hose and the motor operated within motor speed specifications.It was noted that the control bar position was flush with the master control bar.Repair of the air dermatome was performed by zimmer biomet surgical on january 5, 2017 which included replacement of the ball detent, thickness control 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 unconfirmed since during the initial inspection it was noted that the device did not stall during testing.During the initial inspection it was noted that the device did not stall during testing.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 stalled during use.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: 6708715
• MDR Text Key: 79924965
• Report Number: 0001526350-2017-00422
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• 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: 60127781
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1