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 Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

(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 dermatome was returned with information that it needs repair as it experiences loss of power and difficulties with starting up.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4 - udi #: (b)(4).Once an investigation of the device is completed, a follow-up/final report will be submitted.

Event Description

It was reported that while preparing for surgery when staff turned on the dermatome they noted uneven operation of the rollers/blades, like loss of power/stalling.The surgery was completed with an alternate unit.No adverse events were reported as a result of this event.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Product review of the electric dermatome by zimmer biomet on 19 december 2019 revealed that the motor of the device was defective and corroded, the insulation on the cable was damaged, and the unit was out of calibration and the control bar position was not correct.Repair of the electric dermatome was performed by zimmer biomet which included replacement of the plug harness assembly, motor, thickness control shaft, shaft bearings, and sleeve bearings.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, it cannot be determined from the information provided what caused the motor 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.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 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: 9466833
• MDR Text Key: 196208478
• Report Number: 0001526350-2019-01161
• 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,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 63369612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1