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 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (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

Electric dermatome lost suddenly it's power.They managed to take one skin graft and after that the sound of device was changing and the device lost it's power.They had to take another zimmer dermatome to finish the surgery.Delay was only 10 minutes, because another dermatome was very quickly available.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).The device history record for zimmer electric 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 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 to query for all repairs on serial number (b)(6) 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 that a dermatome suddenly lost power.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on 24 june 2019 noted that the device was out of calibration specifications at the zero and ten settings and that the control bar was not in the correct position.Upon further evaluation, it was found that the motor ran above motor speed specifications, that the spring seal was damaged, and that the device required the power cord and power switch update.Repair of the dermatome occurred on 25 june 2019 and involved replacing the motor, multiple screws, the power switch, power cord, and the spring seal as well as recalibrate the device and reposition the control bar to the correct position.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.The service technician was unable to reproduce the reported power loss issue with the dermatome.In addition, the power supply that was used with the device was not returned, so it cannot be determined if the power supply was responsible for the device losing power.As such, 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.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.

Event Description

No additional event information was received.

• 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: 8760298
• MDR Text Key: 150288517
• Report Number: 0001526350-2019-00530
• 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: 09/27/2019

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: 61296373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1