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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05701
• Device Sequence Number: 5660650
• Product Code: LXH
• UDI-Device Identifier: 00888867214729
• UDI-Public: 00888867214729
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown