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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the device makes really loud sound when turned on and it stops working.The event occurred during testing and there was no harm, no delay reported.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number: (b)(4).This report is being filed to relay additional information.D4: udi #: (b)(4).The device history record for zimmer electric dermatome serial number: (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number: (b)(6) prior to 5 june 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On 5 june 2019, it was reported that a dermatome making a really loud sound when turned on and would stop working.The customer returned a zimmer electric dermatome serial number: (b)(6) for evaluation.Evaluation of the device on 19 june 2019 noted that the calibration was out of specifications and that the motor did not run.Upon further evaluation, it was found that the 4" width plate was damaged and that the width plate screws were missing.Repair of the dermatome occurred the same day and involved replacing the motor, cord assembly, switch, 4" width plate, both width plate screws, and multiple bearings.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.The service technician was unable to reproduce the reported noise issue.While the service technician found that the motor did not run, which would prevent the device from being used as intended, it cannot be determined from the information provided as to what caused the motor to fail.As such, a specific cause of the device not working cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information is available.

• 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: 8697462
• MDR Text Key: 148073109
• Report Number: 0001526350-2019-00480
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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 Catalogue Number: 00882100100
• Device Lot Number: 63526280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1