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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.Initial reporter: (b)(6).

Event Description

During kit inspection, it was reported that the dermatome handpiece 'appears lower power.' no adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b4, d4, g4, g7, h2, h3, h4, h6, h8, h10.The device history record and previous repair record for zimmer air 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 the device.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation and repair.On 19 september 2019, it was reported that a dermatome had low power.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on 19 september 2019 noted that the motor ran below motor speed specifications and that it was out of calibration at all four settings.Repair of the dermatome occurred on 5 november 2019 and involved replacing the motor, handpiece switch, multiple bearings, reciprocating arm, and the width plate screws as well as recalibrating the device.The technician then tested and verified that the dermatome was functioning as intended, then returned the dermatome to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the device was running below motor speed specifications, it cannot be determined from the information provided as to what caused this to occur.As such, a specific cause of the reported event 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.

• 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: 9328443
• MDR Text Key: 189608423
• Report Number: 0001526350-2019-01020
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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: 32348700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1