MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 2 8MM; TEMPLATE FOR CLINICAL USE

Model Number IBAL UKA TIB BEA-RING TRL SZ 2 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 12/13/2022

Event Type  malfunction  

Event Description

It was reported on 12/13/2022 by a sales representative via sems that an ar-601-tbb8 tibial bearing cracked off.Case involvement, device broke during use.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

Complaint is confirmed.Upon visual investigation, it was noted that the uni-knee tibial bearing is cracked off and nicks around the edges of the device on both sides.However, the pieces were not returned for investigation.The cause remains normal wear and tear.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 2 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: 16086781
• MDR Text Key: 308501405
• Report Number: 1220246-2023-06012
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00888867037502
• UDI-Public: 00888867037502
• 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: 03/21/2023

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 2 8MM
• Device Catalogue Number: AR-601-TBB8
• Device Lot Number: 6791328
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1