MAUDE Adverse Event Report: ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	130° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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 10/10/2025, a sales representative reported via (b)(4) that a 1268-100 radiolucent targeting arm, 130 degree troch nail, experienced an issue.The es screw trajectory was inaccurate, causing the screw to bind within the nail.The screw cross-threaded, and the surgeon was unable to fully advance it through the nail.As a result, the es screw remained prominent on the lateral cortex of the femur.The case was completed successfully and no piece broke off in the patient.This was identified during a trochanteric nail procedure on (b)(6) 2025, with no reported patient harm.
Event or Problem Description
Additional information was provided on 10/17/2025: the product used with the nail was ar-9094es-11-3930l es trochanteric nail, left.The issue occurred during insertion of the es screw.The surgical team had to manipulate and wiggle the jig in order to insert the screw.The same original part numbers were used to complete the case.This resulted in a five-minute delay and an additional five minutes of anesthesia administration.No photos were taken for documentation, and no adverse effects were reported.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: d4, g3.
Additional Manufacturer Narrative
One unpackaged 1268-100 130° radiolucent targeting arm, batch number 210928, was received for investigation.Visual evaluation noted: damage to the threads of the device surface damage and fading along the body.Functional testing was not performed due to the damage to the device.Most likely reason for the reported failure: misalignment of the targeting arm during screw insertion results in an inaccurate trajectory.Additional contributing factors: manipulation and wiggling of the jig during the procedure may have increased misalignment.Potential user-related factors, such as the technique during assembly and insertion.Refer to the investigation photos.The complaint allegation is confirmed.

• Brand Name: 130° RADIOLUCENT TARGETING ARM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 23325884
• Report Number: 1220246-2025-04674
• Device Sequence Number: 13405040
• Product Code: HSB
• UDI-Device Identifier: 00848665028645
• UDI-Public: (01)00848665028645(11)221208(10)220993
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 130° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1268-100
• Device Lot Number: 210928
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: Not provided; 11/05/2025; 01/26/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/03/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown