BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 12984812 · Received December 13, 2021

    Report

    Report Number
    1220246-2021-04108
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 17, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE TIP OF THE DEVICE BROKE OFF APPROXIMATELY 3MM FROM THE DISTAL END. NO ADDITIONAL DAMAGE WAS OBSERVED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS PRYING/LEVERAGING THE DEVICE DURING USE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL PLAN OF THE SURGERY WAS AN ME WITH THE TWO SCREWS ACCORDING TO MICA, BUT THE DISTAL SCREW SIMPLY BROKE OFF AT APPROX. 5MM. THE REMAINING SCREW REMAINED EMBEDDED IN THE BONE. THE PROXIMAL SCREW COULD BE UNSCREWED WELL AT FIRST UNTIL 7-8 MM OUTSIDE THE BONE. AFTER THAT THE SURGEON WAS NOT ABLE TO MOVE THE SCREW A SINGLE MM. THE SCREW HEAD WAS SCREWED THROUGH AND THE SURGEON WANTED TO GO BACK TO THE INITIALLY PLANNED ME. WHILE IMPLANTING IT THE TIP OF THE EXTRACTOR BROKE OFF AND BLOCKED THE SCREW, SO THAT IT WAS NOT POSSIBLE TO INSERT ANOTHER ATTACHMENT. IN THE END THE SURGEON HAD TO CUT THE PROTRUDING PART OF THE SCREW WITH A SAW BLADE AND LEAVE THE REST OF THE SCREW IN THE BONE. IT IS CURRENTLY UNKNOWN IF THE PATIENT IS HARMED TO THE ISSUE BUT THE SURGERY TIME WAS EXTENDED FROM 5 MINUTES TO 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885028 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1391931

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other