MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 4 8MM; ORTHOPEDIC MANUAL SURG INSTR

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

Device Problem Crack (1135)

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

Event Date 12/04/2023

Event Type  malfunction  

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.

Event Description

On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that during a case, a tibial bearing trial, ar-601-tbd8, cracked.The trial was replaced and the case was completed with no adverse effect to the patient.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18579486
• MDR Text Key: 333728168
• Report Number: 1220246-2024-00527
• 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
• Report Date: 01/25/2024

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: 8791201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1