MAUDE Adverse Event Report: ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	125° RADIOLUCENT TARGETING ARM
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 (b)(6) 2025, it was reported by a sales representative via (b)(4) that a 1267-100 radiolucent targeting arm green button was defective and did not hold the sheath securely and a 5033-100 galileo capturing rod end snapped off when the surgeon unscrewed the rod.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection noted scratches on the surface of the distal end of the metal part of the trochanteric nail.Functional testing was performed and noted that the button, distal screws and button cap (green) did not work activating the bolt, button, and spring button of the radiolucent targeting arm, 125 degree troch nail.The most likely cause of the reported failure can be attributed to user error due to excessive mechanical forces being applied to the button.

• Brand Name: 125° RADIOLUCENT TARGETING ARM
• 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: 21334318
• Report Number: 1220246-2025-00305
• Device Sequence Number: 8550346
• Product Code: HSB
• UDI-Device Identifier: 00848665028652
• UDI-Public: 00848665028652
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 125° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1267-100
• Device Lot Number: UNREADABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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