MAUDE Adverse Event Report: ARTHREX, INC. SOLID LOCKING LAG SCREW, Ø10.5MM X 80MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	SOLID LOCKING LAG SCREW, Ø10.5MM X 80MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/17/2026
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
It was reported that a patient experienced pain a few days after the implantation of a trochanteric nail.As a result, an x-ray was taken, which revealed that the lag screw in the nail had broken.There was no specific incident that led to the breakage.It was reported that the patient left town, which is why no revision surgery was performed.

• Brand Name: SOLID LOCKING LAG SCREW, Ø10.5MM X 80MM
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 25186531
• Report Number: 1220246-2026-02880
• Device Sequence Number: 10702236
• Product Code: HSB
• UDI-Device Identifier: 00848665015683
• UDI-Public: 00848665015683
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: SOLID LOCKING LAG SCREW, Ø10.5MM X 80MM
• Device Catalogue Number: 1094-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown