MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Catalog Number 00882100100

Device Problems Failure to Calibrate (2440); Failure to Cut (2587); Power Problem (3010)

Patient Problems Abrasion (1689); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Electric dermatome was giving bad quality skin grafts and the engine of dermatome was powerless.The event occurred during surgery.No adverse events were reported as a result of this malfunction.

Event Description

Electric dermatome: bad quality skin grafts.The engine of dermatome was powerless.An unplanned additional skin graft needed to be taken from the patient with another device.There was a delay of 15 minutes to exchange the device.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record and previous repair 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 reviews 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)(6) prior to (b)(6) 2019, the device was noted to have been previously repaired three times, the last repair being for the throttle not working as it should reported on (b)(6) 2018.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported from turku university hospital that a dermatome had a powerless motor and was taking bad quality grafts.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on (b)(6) 2019 noted that the device was out of calibration at the zero setting and that the control bar was not in the correct position.Upon further evaluation, it was found that the motor did not run at a constant rate.Repair of the dermatome occurred on (b)(6) 2019 and involved replacing multiple bearings, the retaining ring, motor, power switch, power cord, and multiple screws as well as repositioning the control bar and recalibrating the device.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 powerless motor as the motor powered on during testing.While the technician did find that the control bar was out of position, which could cause the device to not take quality grafts during use, it cannot be determined from the information provided as to what caused the control bar to be out of position.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.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8425049
• MDR Text Key: 139097269
• Report Number: 0001526350-2019-00163
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• 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: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other