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

Model Number	125° RADIOLUCENT TARGETING ARM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22-dec-2025, it was reported by a sales representative via (b)(4) that an 1267-100 radiolucent targeting arm cracked at the metal interface attaching to the nail during impacting of the impactor pad.This was discovered during a trochanteric nail procedure with no patient harm.The case was completed successfully.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged 1267-100 batch 210921 was received for evaluation.Visual inspection revealed a crack at the connection with the metal and regular signs of wear and tear.A functional test was performed by pressing the buttons; friction was noted, which could be due to continuous reprocessing.The most likely cause of the reported failure is wear and tear on the 2021-manufactured device.

• 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: 24036029
• Report Number: 1220246-2026-00134
• Device Sequence Number: 10498364
• Product Code: HSB
• UDI-Device Identifier: 00848665028652
• UDI-Public: (01)00848665028652(11)210903(10)210921
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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): 02/16/2026

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: 125° RADIOLUCENT TARGETING ARM
• Device Catalogue Number: 1267-100
• Device Lot Number: 210921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown