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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the product works few seconds and stops.The event occurred during surgery; no harm and no delay were reported.Another device was used to complete the surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).On june 25, 2018, it was reported that the product works few seconds and stops.The customer returned an electric dermatome device, serial number: (b)(4), for evaluation.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Medicrea has previously repaired/evaluated electric dermatome serial number: (b)(4) as documented in the repair reports in vdoc portal services.The last repair was june 14, 2018 where it was reported that does not work anymore and the bearings, spring seal, motor, switch, plug harness assembly, seal/strain relief, control bar, reciprocating arm pack were replaced.This is not a related issue.Product review of the electric dermatome by medicrea on july 25, 2018 revealed that the motor was corroded.It was also noted that the lift and reciprocating arm were worn.It was also noted that the screws were missing in the head repair of the electric dermatome was not performed by medicrea on august 3, 2018 as the customer denied the repair quote and requested to destroy the device.The reported event was confirmed since during product review it was revealed that the motor was corroded.It was also noted that the lift and reciprocating arm were worn.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was revealed that the motor was corroded.It was also noted that the lift and reciprocating arm were worn.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.

• 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: 7753429
• MDR Text Key: 116239461
• Report Number: 0001526350-2018-00677
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 60105323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1