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

Model Number	IBAL UKA, FEMORAL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/06/2024 it was reported by a sales representative via sems (b)(4) that an ar-611-6 femoral impactor tip of the device that connects to femur broke off while being hammered.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-611-6 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed due to device head being broken.Upon visual inspection, it was observed that the device's head is broken; however, half of the material remains attached to the handle.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: 20135177
• Report Number: 1220246-2024-07349
• Device Sequence Number: 17979537
• Product Code: LXH
• UDI-Device Identifier: 00888867223875
• UDI-Public: 00888867223875
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/30/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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