MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, FEMORAL IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA, FEMORAL IMPACTOR
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
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 02/12/2024, it was reported by a sales representative via (b)(4) that an ibal uka femoral impactor, ar-611-6, is cracked on the end.Occurred during a case, no adverse effect to the patient.
Additional Manufacturer Narrative
Complaint is confirmed.The visual inspection identified that the head of the ibalance® uka sportsplasty¿, femoral impactor had cracked, signs of wear and scratches.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Device was manufactured on 02/2016.

• Brand Name: IBAL UKA, FEMORAL IMPACTOR
• 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: 18806666
• Report Number: 1220246-2024-01202
• Device Sequence Number: 7360858
• Product Code: LXH
• UDI-Device Identifier: 00888867223875
• UDI-Public: 00888867223875
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/27/2024

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 UKA, FEMORAL IMPACTOR
• Device Catalogue Number: AR-611-6
• Device Lot Number: 37621552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown