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

Model Number N/A

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.

Event Description

It was reported that the dermatome was not working as should.The device first powered up, but then stopped working.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The customer returned an electric dermatome device for evaluation.The device history record (dhr) 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.Zimmer biomet surgical/ medicrea has not previously repaired/evaluated this electric dermatome.Initial qa inspection of the electric dermatome by medicrea revealed that the motor speed was within specification at 5700 rpm.The power switch was damaged.Repair of the electric dermatome was performed by medicrea which included replacement of the ball bearing, spring seal, needle bearing, semi-circle bearings, vespel sleeve bearings, motor, handpiece switch, and divers.Electric dermatome was then tested and functioned properly.It was repaired, inspected and tested.The reported event was non-verifiable since during initial inspection the device functioned as intended and it is unknown if the power switch caused any issues related to the reported issue.The root cause of the device not working after it was powered up could not be determined since it is unknown since the device functioned as intended and it is unknown if the power switch caused any issues related to the reported issue.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Electric dermatome was repaired, tested and returned to the customer.No further conclusions can be drawn from the complaint history review that warrants further action.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7409799
• MDR Text Key: 104894498
• Report Number: 0001526350-2018-00306
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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: 62812850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1