MAUDE Adverse Event Report: ARTHREX, INC. CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection, it was noted that threads of the captured cortical screw, ø5.0mm x 36mm were damaged.Functional testing was performed and noted that the screw did not work as required due to the damaged of the threads.Per surgical technique nail system: the es hole is easily targeted through the nail jig without the need for perfect circles or additional attachments or devices.Preoperative planning preoperative radiographs of the uninjured femur may be used to establish proper nail diameter, expected amount of reaming (if necessary), lag screw angle, nail length, and lag screw length.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.
Event or Problem Description
It was reported that during an intertrochanteric fracture surgery the lag screw and anti-rotation screw backed out of the nail and the nail lagscrew hole looked damaged.It was further reported that the patient went in for a total hip replacement on the (b)(6) 2024.Update dw 21-may-2025 during the evaluation it was found that in addition a 8001-036 was returned as well.

• Brand Name: CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM
• 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: 22282287
• Report Number: 1220246-2025-02504
• Device Sequence Number: 8467166
• Product Code: HSB
• UDI-Device Identifier: 00848665019131
• UDI-Public: 00848665019131
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/18/2025

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: CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM
• Device Catalogue Number: 8001-036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/18/2025
• 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