MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. WIDTH PLATE, NEUTRAL, 2 IN.; DERMATOME

Model Number N/A

Device Problems Unstable (1667); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).G2 foreign: netherlands.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00577, 0001526350-2023-01683.The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the width plate was damaged; however, the repair was not completed because width plates are not repairable.The width plates were returned to the customer as is.Lot/serial identification is necessary for review of device history records, and lot/serial identification was not provided.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

It was reported that the motor speed was not stable and there was a damaged width plate.The event timing was during preventive maintenance.There was no harm or delay reported.Due diligence is complete and no additional information is available.At product evaluation investigation the width plate was confirmed damaged.No adverse events were reported as a result of this malfunction.

• Brand Name: WIDTH PLATE, NEUTRAL, 2 IN.
• 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: 18410850
• MDR Text Key: 331532857
• Report Number: 0001526350-2023-01682
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 8870N200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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