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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device stopped working when pressure was applied.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Reported issue: on july 19, 2019, it was reported that the device stopped working when pressure was applied.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Dhr review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome serial number (b)(4)as documented in the repair reports.Device evaluations results/investigation findings: product review of the electric dermatome on july 20, 2019 revealed that the calibration was out of specifications at the zero and 10 settings.The motor ran erratic and the control bar was in the correct position.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by zimmer biomet surgical on july 20, 2019 which included replacement of the screws, o-ring, plug harness assembly, needle bearing, bearings, seal/strain relief, switch, motor, ball plunger, die case lever, semi-circle bearings, and vespel bearings.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the components to fail.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: 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 trended for any adverse trends that may warrant further action.

Event Description

No additional event information 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: 8896317
• MDR Text Key: 154742689
• Report Number: 0001526350-2019-00653
• 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: 10/03/2019

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: 60032028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1