MAUDE Adverse Event Report: ARTHREX, INC. CANCELLOUS SCREW, Ø6.5MM X 85MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	CANCELLOUS SCREW, Ø6.5MM X 85MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/20/2024, it was reported by a sales representative via phone that a 1310-040 antegrade femoral nail had been cracked inside the patient and was experiencing pain, which was confirmed by an x-ray done on the patient last week.During the original procedure of an orif left femur fracture procedure on 12/1/2023, a (1) 1310-040 antegrade femoral nail/batch: 462737, (1) 8001-050 captured cortical screw/batch: unknown / (1) 8001-055 captured cortical screw/batch: unknown, (2) 8065-085 cancellous screw/batch: unknown and batch: 472747, (1) 8065-090 cancellous screw/batch: 220505 arthrex products were implanted.The original procedure had no issues reported and was completed successfully.The removal of hardware and repair of the left femoral orif fracture revision procedure occurred on 2/20/2024.The arthrex products that were explanted were (1) 1310-040 antegrade femoral nail/batch: 462737, (1) 8001-050 captured cortical screw/batch: unknown / (1) 8001-055 captured cortical screw/batch: unknown, (2) 8065-085 cancellous screw/batch: unknown and batch: 472747, (1) 8065-090 cancellous screw/batch: 220505.Additional information for the arthrex products implanted during the revision has yet to be discovered since the surgery has yet to be completed.Both original surgery and revision surgery took place at the same facility.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The device was not returned for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is a patient-specific event.The complaint allegation was confirmed based on the customer's attached picture showing a damaged device.

• Brand Name: CANCELLOUS SCREW, Ø6.5MM 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: 18857594
• Report Number: 1220246-2024-01348
• Device Sequence Number: 3325289
• Product Code: HSB
• UDI-Device Identifier: 00848665022957
• UDI-Public: 00848665022957
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: CANCELLOUS SCREW, Ø6.5MM X 85MM
• Device Catalogue Number: 8065-085
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown