MAUDE Adverse Event Report: ARTHREX, INC. IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2022

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) 2022, it was reported by a sales representative via sems that a ar-623-55 femoral cutting block broke.This occurred on (b)(6) 2022 during a total knee arthroplasty as the surgeon was removing the size 5 cutting block (ar-623-55) from the femur, a piece in the center of the block broke off preventing the slap hammer to engage with the block.The patient had good bone quality.The case was completed when the surgeon made his femoral cuts and was able to get the block halfway out before it broke.After that, he used a mallet and other miscellaneous instrumentation on the back table provided by the or to remove the block.The case went on per usual after that.

Manufacturer Narrative

Complaint confirmed.Upon visual evaluation, it was noted that the key seat geometry feature of the femoral cutting block had broken and scratches between slots.No fragments were returned for investigation.The cause of this remains undetermined, however a probable cause can be attributed to excessive force applied against with the hammer to engage with the block.

• Brand Name: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15742775
• MDR Text Key: 307065553
• Report Number: 1220246-2022-05701
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867214729
• UDI-Public: 00888867214729
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5
• Device Catalogue Number: AR-623-55
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2022
• 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