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

Model Number N/A

Device Problem Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign - (b)(6).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

Zimmer dermatone handle stopped working.The event took place during routine inspection.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This follow up report is being submitted to report additional information.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 6 february 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) clinic that a dermatome handle stopped working.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device on 10 april 2019 noted that the device was out of calibration at the zero setting, the control bar was out of position, and that the motor ran above motor speed specifications.Upon further evaluation, it was found that there had been a non-conforming silicon used on the device and that the device only operated intermittently.Repair of the dermatome occurred on 17 may 2019 and involved replacing the motor and needle bearing as well as recalibrating the device and cleaning off the non-conforming silicon.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.Product evaluation confirmed that was not running consistently, which would give the appearance that the handle was not working as intended during use, and the device functioned properly after the motor and needle bearing were replaced.However, it cannot be determined as to what caused the motor and needle bearing to break down and cause the noted failure.As such, a specific cause of the handle not working cannot be determined.During evaluation of the device, the technician did note that a non-conforming silicon had been used with the device.The instructions for use for the zimmer electric dermatome state to not disassemble the handpiece, that there are no user serviceable parts inside of the device, and dermatome should be returned to zimmer surgical for all servicing.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 8383775
• MDR Text Key: 137733549
• Report Number: 0001526350-2019-00146
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• 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: 62635770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1