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

Model Number N/A

Device Problem Device Stops Intermittently (1599)

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

Event Date 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On (b)(6) 2016, it was reported that the case needs repaired and there were boot problems.There was a delay of 30 minutes.On (b)(6) 2016, it was clarified that the issue occurred during surgery.The surgery was completed with another device but there were no additional surgical procedures required.There was no harm or injury to the patient or operator and there were no contributing conditions related to the event.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome serial number (b)(4) as documented in the repair reports in livelink.Electric dermatome, serial number (b)(4), was manufactured on october 29, 2010, is over 5 years old at the time this complaint was generated.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 electric dermatome by zimmer biomet (b)(4) on (b)(4) 2016 revealed that the motor was measuring 0 rpm.The control lever torque testing was not performed.The control bar was flush with the master blade.The device was out of calibration at all 4 settings.Repair of the electric dermatome was performed by zimmer biomet (b)(4) on (b)(4) 2016 which included replacement of the vespel sleeve bearings, semi-circle bearings, screws, handpiece switch, motor and ball bearing.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during initial inspection the motor was measuring at 0 rpm.There was no mention of a case needing repaired in the initial inspection.The root cause of the device having boot problems was due to a defective motor.The issue was resolved with the replaced the vespel sleeve bearings, semi-circle bearings, screws, handpiece switch, motor and ball bearing.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Electric dermatome, serial number (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 w as reported that during surgery, the product stopped working.There was a 30 minute delay.No additional consequences have been reported as a result of this malfunction.

• Brand Name: HANDPIECE, ELECTRIC 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: 6966215
• MDR Text Key: 90683044
• Report Number: 0001526350-2017-00773
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• 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: 00882100100
• Device Lot Number: 61632117
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2010
• 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