BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 20352445 · Received October 2, 2024

    Report

    Report Number
    1220246-2024-07925
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028652
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1267-100 RADIOLUCENT TARGETING ARM LOT NUMBER: 210918 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT A PIN WAS MISSING NEAR THE NAIL ATTACHMENT AREA. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE REPORTED FAILURE WAS CONFIRMED VISUALLY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/USER ERROR OF THE DEVICE DUE TO USER-APPLIED EXCESSIVE MECHANICAL FORCES DURING IMPACTATION. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A 1267-100 RADIOLUCENT TARGETING ARM¿S METAL PIECE HAD BROKEN OFF OF THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/27/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THE METAL PIN CAME OUT DURING A LAG SCREW REMOVAL/REPLACEMENT PROCEDURE. THE SURGEON EXPRESSED THAT THE TELESCOPING LAG SCREW WAS TOO LONG AND THE LAG SCREW DID NOT LOCK INTO THE NAIL FROM THE FIRST SURGERY THAT WAS PERFORMED ALMOST THREE MONTHS PRIOR, AND THE LAG SCREW WAS BACKING OUT. THE SURGEON ATTEMPTED TO PLACE THE JIG BACK ONTO THE TROCH NAIL WHICH WAS LOCATED INSIDE THE FEMUR FROM A PREVIOUS SURGERY. A 3.2 GUIDEWIRE WAS USED TO GUIDE THE JIG ONTO THE BACK OF THE NAIL. THE JIG WAS ROTATED SEVERAL TIMES TO TRY AND FULLY SEAT ONTO THE NAIL, BUT THERE WAS SOME GAPPING THAT THE SURGEON WAS NOT SATISFIED WITH. THE IMPACTOR PAD WAS ASSEMBLED TO THE JIG AND THE SURGEON TRIED TO MALLET THE JIG ONTO THE NAIL. A NAIL WAS PULLED TO SHOW THE SURGEON HOW THE SLOTS NEEDED TO LINE UP, AND AGAIN SEVERAL ATTEMPTS WERE MADE TO PLACE THE JIG. ONE OF THE METAL PINS THAT HOLD THE SILVER END OF THE JIG POPPED OUT AND WAS STUCK IN THE SOFT TISSUE. IT WAS NOTICED ON X-RAY AND WAS RETRIEVED BY THE SURGEON UNDER X-RAY OUT OF THE SOFT TISSUE WITH A PITUITARY RONGEUR. ONCE THAT PIECE WAS RETRIEVED, THE SURGEON DECIDED TO NOT USE THE JIG AND USED EXTENSIVE X-RAY AND FREE-HANDED THE REMOVAL OF THE OLD LAG SCREW AND FREE-HANDED PUTTING IN THE NEW LAG SCREW. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ON 10/17/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THE ADDITIONAL SURGERY WAS DELAYED BY 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT HAS BEEN FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161606 125° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 220990A 00848665028652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown