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 07/05/2019

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.Item number: 00882100600, power supply, elec.Dermatome, serial number: (b)(4).

Event Description

It was reported that the equipment stops working when it is operated several times, and it gets heated.No adverse events were reported as a result of this malfunction.

Event Description

Device was not hot to touch and no one was burnt or injured as a result.No adverse events were reported as a result of this malfunction.No additional event information is available.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(6).Product review of the electric dermatome by zimmer biomet on (b)(6) 2019 revealed that the device was not functioning due to a defective motor and needle bearing.Repair of the electric dermatome was performed by zimmer biomet which included replacement of the motor and needle bearing.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Although the reported event was confirmed during inspection of the device, and the device was found to be functioning as intended after the motor and needle bearing were replaced, it cannot be determined from the information provided what caused the components to fail.Therefore, the root cause 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 (ie/capa/scar/hhe/d).This complaint will be tracked and 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: 8792611
• MDR Text Key: 151110135
• Report Number: 0001526350-2019-00551
• 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: 10/29/2019

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: 61991955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1