MAUDE Adverse Event Report: ARTHREX, INC. TELESCOPING LAG SCREW, LT, 10.5 X 85MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	TELESCOPING LAG SCREW, LT, 10.5 X 85MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
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
On 08-jan-2026, it was reported by a sales representative via phone that an ar-9094-090l left lag screw, an ar-s0100-381 guide pin, an ar-s0457-000 activation tool, ar-s0100-000 guide pin, ar-s0219-100 drill, ar-s0209-200 drill, ar-9094-11-2030 trochanteric nail, and an ar-9094-085l lag screw were used in a case and neither screw were able to lock into the nail after implantation.All implants were fully explanted, and the surgery was completed using a competitor product nail.This occurred during use in a case with no patient effect.Delay in case 50 minutes.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the inserter within the screw during use.

• Brand Name: TELESCOPING LAG SCREW, LT, 10.5 X 85MM
• 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: 24234138
• Report Number: 1220246-2026-00350
• Device Sequence Number: 13319265
• Product Code: HSB
• UDI-Device Identifier: 00888867409989
• UDI-Public: (01)00888867409989(11)250312(17)300228(10)15403394
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• 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): 05/18/2026

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: TELESCOPING LAG SCREW, LT, 10.5 X 85MM
• Device Catalogue Number: AR-9094-085L
• Device Lot Number: 15403394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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