MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 4 8MM; TEMPLATE FOR CLINICAL USE

Model Number IBAL UKA TIB BEA-RING TRL SZ 4 8MM

Device Problem Break (1069)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that a ar-601-tbd8 tibial bearing trial is damaged.This occurred during a case, with no patient effect reported.During returned device evaluation, a reportable malfunction was discovered.

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint is confirmed.One unpackaged ar-601-tbd8 serial/batch number (b)(4) was received for investigation.Visual inspection found that the ibalance uka tibial bearing trial had broken off at the elliptical profile.No fragments were returned for analysis.The root cause of the reported failure mode is undetermined; however, the observed event is most likely caused by excessive bending forces applied during use.

Manufacturer Narrative

Complaint is confirmed.One unpackaged ar-601-tbd8 serial/batch number: (b)(6) was received for investigation.Visual inspection found that the ibalance uka tibial bearing trial had broken off at the elliptical profile.No fragments were returned for analysis.The root cause of the reported failure mode is undetermined; however, the observed event is most likely caused by excessive bending forces applied during use.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Type of Device: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16387074
• MDR Text Key: 309987532
• Report Number: 1220246-2023-06308
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00888867037625
• UDI-Public: 00888867037625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Device Catalogue Number: AR-601-TBD8
• Device Lot Number: 5261721
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1