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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).(b)(6).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 device stops working suddenly and then starts working again.Device can harm the graft.In this case the first graft was not usable and they had to take several grafts.Some of these were usable.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch has been filed to relay additional information.The device history 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 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)(4) prior to (b)(6) 2018, 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) 2018, it was reported from kymenlaakso central hospital that a dermatome would stop working and then start working again.The customer returned a zimmer electric dermatome serial number 203917 for evaluation.Evaluation of the device on (b)(6) 2019 noted that the device was out of calibration at all four settings, but ran within motor speed specifications.Upon further evaluation, it was found that the power switch was damaged.Repair of the device occurred on (b)(6) 2019 and involved replacing the power switch, motor, plug harness assembly, and multiple washers.The technician then tested the device and verified that the dermatome was functioning as intended.The device was then returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the power switch was damaged, which would make it difficult for the device to be used and maintain consistent motor speed during use, it cannot be determined from the information provided as to what caused the damage to the switch.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
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8239957
• MDR Text Key: 132803482
• Report Number: 0001526350-2019-00016
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 61296373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other