MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED

Model Number N/A

Device Problems Calibration Problem (2890); Material Deformation (2976); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported during maintenance that the following failure descriptions were noted: control bar issue; motor issue; worn screws; damaged machined head; calibration issue; plug harness issue handpiece switch issue.There was no reported patient harm, or delay as there was no involvement.At the evaluation it was found that the motor was unstable.Due diligence is complete, no further information is available at this time.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.E1 phone: (b)(6) g2 foreign: united kingdom review of the most recent repair record determined the control bar and the unit were out of calibration, the motor speed was unstable, the motor insulator sleeve was missing, some screws were worn, the machined head was damaged, and there was some potential corrosion on the reciprocating arm.The motor, insulator sleeve, screws, machined head and reciprocating arm were replaced and the control bar and unit were calibrated to resolve the reported issue.There was no issue with the switch and the plug harness assembly, they were only replaced as a part of an update to have lead free soldering.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME HANDPIECE, ELECTRICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17600389
• MDR Text Key: 321715248
• Report Number: 0001526350-2023-00957
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: 32120000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose