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

Catalog Number 00882100100

Device Problems Material Frayed (1262); Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

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 had power but stopped and started but the lead was broken on the hand piece.The issue occurred prior to surgery.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

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 the device.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 28 may 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 28 may 2019, it was reported that a dermatome had power but stopped and started.The device had a broken lead on the handpiece.The customer returned a zimmer electric dermatome serial number (b)(6) for evaluation.Evaluation of the device by zimmer australia on 27 may 2019 noted that the dermatome was running slow and erratic and had a worn head.The device was forwarded to zimmer taiwan for further evaluation.Evaluation of the dermatome by zimmer taiwan on 6 june 2019 noted that the device was out of calibration at all four settings and that the motor on the dermatome ran below motor speed specifications.Upon further evaluation, it was found that the bearings, an o-ring, seal, reciprocating arm, external e-ring, harness assembly plug, the machined head, and width plate screws were defective.Repair of the device occurred on 12 june 2019 and involved replacing the motor, handpiece switch, bearings, o-ring, seal, reciprocating arm, external e-ring, harness assembly plug, machined head, and width plate screws as well as recalibrating the device.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 28 may 2019.While the service technician found that the motor was not running consistently and that the harness assembly plug was damaged, which would cause the motor to not run properly, it cannot be determined from the information provided as to what caused the damage to the harness assembly plug such that the device would not power on properly.As such, 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: 8699982
• MDR Text Key: 148070986
• Report Number: 0001526350-2019-00473
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 30259100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1