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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On (b)(6) 2017, it was reported that the device does not stay on.It suddenly stopped working.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet (b)(4) has not previously repaired/evaluated electric dermatome serial number (b)(4) as documented in the repair reports in livelink.Product review of the electric dermatome by zimmer biomet (b)(4) on (b)(4) 2017 revealed that the motor/switch failure was able to be confirmed.The device was disassembled and cleaned and the thickness adjustment was checked and overhauled.Repair of the electric dermatome was performed by zimmer biomet (b)(4) on (b)(4) 2017 which included replacement of the motor, switch, plug harness assembly, spring seal, needle bearing, lever and ball plunger.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 the product review by zimmer biomet (b)(4) it was noted that the motor/switch failure was able to be replicated.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet (b)(4) it was noted that the motor/switch failure was able to be replicated.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.External contractor.

Event Description

It was reported that the device does not stay on and suddenly stopped working.No adverse events were 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: 8061325
• MDR Text Key: 128582623
• Report Number: 0001526350-2018-00492
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2018

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 Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 31717000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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