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

Model Number N/A

Device Problems Corroded (1131); Unstable (1667); Calibration Problem (2890); Naturally Worn (2988)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that the motor speed was unstable, calibration issue, worn reciprocation arm and corroded motor.The event timing was during preventative maintenance.There is no harm or delay reported.No adverse events were reported as a result of this malfunction.Due diligence is complete and there is no additional information available.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.G2: foreign country - france.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.

Manufacturer Narrative

Review of the most recent repair record determined that the unit was out of calibration, arm was worn and that the motor failed.The motor and reciprocation arm were replaced, the device was recalibrated, and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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.

Event Description

There is 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
• 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: 18101592
• MDR Text Key: 327731399
• Report Number: 0001526350-2023-01486
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 0088904375994
• UDI-Public: (01)0088904375994(11)170727(10)63733145
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 63733145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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