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

Model Number N/A

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On may 19, 2016, it was reported that the device stopped working when the blade was attached.The issue occurred during surgery with no harm or delay.On june 17, 2016, it was clarified that the blade was placed properly and the dermacarrier was at room temperature.The device was not repaired by someone other than zimmer biomet and no medical intervention/additional surgical procedure was required.On june 21, 2016, it was clarified that the surgical technique for the product was utilized.The customer returned an air dermatome device, serial (b)(4), for evaluation.The customer also returned a hose (serial (b)(4)), for evaluation.Zimmer biomet (b)(4) has previously repaired/evaluated air dermatome serial (b)(4) once as documented in the repair reports in livelink.The last repair was (b)(6) 2013 where it was reported that the device was not working and the ball detent, machine head, control bar, thickness control lever, reciprocating arm, bearings, seal and retaining ring, motor, poppet assembly, width and o-ring were replaced.This is not a related issue.The device history record (dhr) and previous repair report review 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 by zimmer biomet (b)(4) on (b)(6) 2016 revealed that the motor was running below speed specification at 4,050 rpm.The device was out of calibration at all four settings.The device passed the blade contact surface, swivel (leak/ mobility), control bar, blade connection interface, visual inspections.Repair of the air dermatome was performed by zimmer biomet (b)(4) on july 15, 2016 which included replacement of the machine head, semicircle shaft bearings, vespel sleeve bearing, motor, ball bearings, o-rings, poppet housing, motor sleeve, spring seal, needle bearing, external e-ring and reciprocating arm.Air dermatome, serial (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was non-verifiable since during initial inspection the motor was running below specification.The device passed the blade contact surface and blade connection interface inspection.The root cause of the device stopping when the blade was attached cannot be specifically determined with the provided information since the device running during initial inspection.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Air dermatome, serial (b)(4), was repaired, tested and returned to the customer.No further conclusions can be drawn from the complaint history review that warrants further action.

Event Description

It was reported that during surgery the air dermatome stopped working when the blade was attached.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: 7221871
• MDR Text Key: 98548379
• Report Number: 0001526350-2018-00099
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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: 31754500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/1998
• 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