MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 8, 12MM; ORTHOPAEDIC TEMPLATE

Model Number IBAL TKA,TIB BEARING TRL SZ 8, 12MM

Device Problem Break (1069)

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

Event Date 03/25/2024

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 an ar-623-t812 ibalance tka, tibial bearing trial size 8 was broken during use with no further information provided.There was no effects to the patient reported.This was discovered during a procedure.Additional information was received on 3/29/2024: the impactor was broken when the tibial implant was implanted; the poly trial broke when attempting to trial the sizes.The device broke while being put into the patient, and all fragments were retrieved from the patient.The case was delayed by about a minute when switching to another poly trial size.The case was completed with another trial and finished normally with no adverse effects on the patient.This was discovered during a total knee arthroplasty procedure on (b)(6) 2024.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 8, 12MM
• Type of Device: ORTHOPAEDIC TEMPLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19146753
• MDR Text Key: 340679179
• Report Number: 1220246-2024-02182
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00888867215405
• UDI-Public: 00888867215405
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBAL TKA,TIB BEARING TRL SZ 8, 12MM
• Device Catalogue Number: AR-623-T812
• Device Lot Number: 132581531
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1