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

Model Number N/A

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that dermatome had a decontamination certificate stating the device had no power or loss of power.No further information provided.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, as final medwatch.Investigation completed.The device history record for zimmer electric dermatome serial number (b)(4) 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 and the medicrea database to query for all repairs on serial number (b)(4) prior to (b)(6) 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 (b)(6) 2019, it was reported from (b)(6) that a dermatome did not have power.The customer returned a zimmer electric dermatome serial number (b)(4) for evaluation.Evaluation of the device on 25 march 2019 noted that the device was out of calibration at the zero, ten, and twenty settings and that the control bar was not in the correct position.Upon further evaluation, the motor was found to not run, the needle bearing was worn, and the eccentric shaft was damaged.Repair of the dermatome occurred on 21 may 2019 and involved replacing the motor, power switch, power cord, needle bearing, eccentric shaft, multiple bearings, and multiple screws.The technician then tested and verified that the device was functioning as intended, and then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the motor was not running on the device, it cannot be determined from the information provided as to what caused the motor to not run properly.Therefore, a specific root 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.

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: 8482637
• MDR Text Key: 140909267
• Report Number: 0001526350-2019-00216
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 33384600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1