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 03/29/2019

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

The device stops during the procedure, after a short "rest" it starts to work for a while and stops again.No harm or delay was reported.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by 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 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 to query for all repairs on serial number (b)(6) prior to 4 april 2019, the device was noted to have not been previously repaired.Review of the complaint history based on the above keywords found no other similar events related to the reported device; as such, no further additional action is required at this time.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 would start up and then stop during use.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device noted that there were damaged screws and compression cap, that the device was out of calibration, the control bar was not in the correct position, that the device did not run within motor speed specifications and that the motor heated up during use.At the time of the investigation, the screws, motor, needle bearing, and spring seal have been replaced and the control bar adjusted, but the device was put on a materials hold and has yet to be completely repaired.The device was tested and inspected.While the service technician found that the motor was heating up and was running below motor speed specifications, which would be indicative of the motor not moving the reciprocating arm as intended and lead to the device starting and stopping during use, it cannot be determined from the information provided as to what caused the damage to the motor such that it would heat up and not produce adequate motor speed.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.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 per complaint trending procedure 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: 8562313
• MDR Text Key: 143962484
• Report Number: 0001526350-2019-00316
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• 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: 62042429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1