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

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Calibration Problem (2890); Material Deformation (2976)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported the following unit was sent in for maintenance but in need of repair due to calibration issue; defective motor need to be replaced; damaged plug harness assembly need to be replaced, damaged machined head need to be replaced.Upon it was noted motor speed was unstable.No other adverse events were reported as it relates to this event.

Manufacturer Narrative

This incident has been recorded under (b)(4).Review of the most recent repair record determined that the unit was out of calibration, the motor speed was unstable, the machined head was damaged, and the plug harness assembly was damaged.The plug harness assembly, machined head, bearings, and motor were replaced to resolve the reported issue.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: ELECTRIC DERMATOME SYSTEM
• 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: 15147619
• MDR Text Key: 304359107
• Report Number: 0001526350-2022-00673
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• 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: 00882100000
• Device Lot Number: 30648800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/1995
• 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