MAUDE Adverse Event Report: ARTHREX, INC. IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 9; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 9
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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) 2023, it was reported by an arthrex employee via sems that an ar-623-59 ibalance® tka, femoral cutting block had an issue.The piece that connects to the slap hammer cracked.All pieces were retrieved without harm on patient.This was discovered during an unspecified procedure on (b)(6) 2023, with no adverse event or patient harm.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.Manufactured date: 14-may-2020.
Event or Problem Description
Additional information received on 8/29/2023: this was discovered during a total knee replacement procedure on (b)(6) 2023.The case was completed by opening a new tray with no delay in the procedure.

• Brand Name: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 9
• 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: emily shafer ; 8009337001
• MDR Report Key: 17653333
• Report Number: 1220246-2023-07681
• Device Sequence Number: 15298936
• Product Code: LXH
• UDI-Device Identifier: 00888867214767
• UDI-Public: 00888867214767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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 9
• Device Catalogue Number: AR-623-59
• Device Lot Number: 1126902020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown