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

Model Number	IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Visual evaluation reveals that the instrument attachment feature of the femoral cutting block is broken.The observed condition is attributed to undetermined.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces during use.
Event or Problem Description
It was reported on 11/01/2022 by a sales representative via sems that an ar-623-55 cutting guide broke off inside the ar-613-99 slap hammer.Case involvement, no patient effect.Nothing broke off inside the patient.

• Brand Name: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5
• Common Device Name: 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: jared engle ; 8009337001
• MDR Report Key: 19399353
• Report Number: 1220246-2024-03975
• Device Sequence Number: 8456530
• Product Code: LXH
• UDI-Device Identifier: 00888867214729
• UDI-Public: 00888867214729
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 05/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 5
• Device Catalogue Number: AR-623-55
• Device Lot Number: 1126902019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown