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

Catalog Number 00882100100

Device Problems Corroded (1131); Failure to Power Up (1476)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

It was reported the motor was corroded.The event timing was during preventive maintenance.There was no harm or delay reported.No adverse events were reported as a result of this malfunction during inspection it was found that the motor speed was unstable.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the motor was corroded, and the motor speed was unstable.The motor was replaced and resolved the reported issue.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, LINE-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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14138005
• MDR Text Key: 289492673
• Report Number: 0001526350-2022-00361
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 65006209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1