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

Catalog Number 00882100100

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It was reported that an electric dermatome was sent in for maintenance but repairs were needed.The repairs were recalibration; defective cable replaced; missing screws replaced, defective needle bearing replaced; defective motor replaced.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay 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 the device.The record review 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.On (b)(6) 2019, it was reported that during evaluation, it was found that the dermatome needed recalibrated, had a defective cable, missing screws, and a defective needle bearing and motor.A zimmer electric dermatome serial number (b)(6) was already at a zimmer facility and was available for evaluation.Evaluation of the device noted that the insulation of the cable was damaged, it was missing the fine adjustment cams, had a worn needle bearing, the control bar was not in the correct position and the product was out of calibration, and that the motor did not start up and would heat up.At the time of the investigation, the product has yet to be repaired and is awaiting quotation approval from the customer.While the service technician found that the device was out of calibration and had an out of position control bar, had a defective needle bearing, a motor that did not run properly, and a damaged power cord, all failures that would require service on the device, it cannot be determined from the information provided as to what caused these issues with the device.In addition, while the technician does find that the fine adjustment cams were missing, no screws on the device were noted to be missing or defective during evaluation of the product.As such, a specific cause for the reported issues 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 for any adverse trends that may warrant further action.

Event Description

No additional event information available.

• 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: 9338828
• MDR Text Key: 189612048
• Report Number: 0001526350-2019-01022
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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: 62441611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1