MAUDE Adverse Event Report: ARTHREX, INC. TELESCOPING LAG SCREW, 10.5 MM X 90 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	TELESCOPING LAG SCREW, 10.5 MM X 90 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the nailing of the proximal femur on (b)(6) 2026, the telescoping lag screw was inserted into the bone at the wrong angle.Due to this failure the surgeon attempted to remove the screw, however due to the incorrect insertion the screw became jammed.The surgeon decided that the fixation should be sufficient and therefore the screw was left in place.It was further reported that during the attempt of removing the screw, the instruments used were bent as well.Not long after the initial surgery, it was discovered that the implanted device had failed and the nail had detached from the bone.For this reason, a revision surgery was performed on (b)(6) 2026, during which all parts were replaced with new devices with the same part numbers.Except the surgeon decided to use a nail with a longer shaft to ensure proper fixation.The revision surgery was performed successful, and no further action is planned.
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.One unpackaged ar-9094-090 telescoping lag screw, was received for investigation.Visual inspection revealed that the screw was attached to an ar-9094-11-2030 trochanteric nail, 11mm x 20cm x 130°.The screw had significant surface damage consistent with the implantation and explantation process.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-related factors, specifically incorrect angulation during insertion of the telescoping lag screw.The complaint allegation is complete.Refer to the investigation photos.

• Brand Name: TELESCOPING LAG SCREW, 10.5 MM X 90 MM
• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24711887
• Report Number: 1220246-2026-01690
• Device Sequence Number: 14884718
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230257
• 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,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TELESCOPING LAG SCREW, 10.5 MM X 90 MM
• Device Catalogue Number: AR-9094-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown