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

Catalog Number 00882100100

Device Problem Electrical Shorting (2926)

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

Event Date 01/02/2019

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

It was reported that the device power cord was cut.The event occurred during reprocessing there was no harm and no delay reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, d4, d10, g4, g7, h2, h3, h4, h6, h10 the device history record and previous repair 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 reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation and repair.On 4 january 2019, it was reported from trimedx that a dermatome had its power cord cut.The customer returned a zimmer electric dermatome, serial number (b)(4), for evaluation.Evaluation of the device on 14 january 2019 noted that the power cord was damaged, but the device was still within side to side calibration and motor speed specifications.The control bar was also found to be in the correct position.Repair of the device occurred the same day and involved replacing the power cord, motor, power switch, and multiple bearings.The technician then tested and verified that the dermatome was functioning as intended and the device was returned to the customer without further incident.The device was tested, inspected, and repaired.Reference number (b)(4) on 4 january 2019.While the service technician confirmed that the power cord had been damaged, it cannot be determined from the information provided as to what transpired such that the power cord became damaged.Therefore, a specific root cause of the cut power cord 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 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: 8223843
• MDR Text Key: 132359666
• Report Number: 0001526350-2019-00008
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• 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: 63138521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1