BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE

    MDR report key: 10461335 · Received August 27, 2020

    Report

    Report Number
    3006494201-2020-00004
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    July 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    CORELINK SURGICAL LLC
    Product Code
    KWQ
    UDI-DI
    M72520201020
    PMA / PMN Number
    K121514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT WAS INSPECTED, AT WHICH POINT THE FRACTURE WAS VERIFIED. DURING INSPECTION, THE TWISTING SEEN ON THE TIP OF THE INSTRUMENT INDICATED THAT THE DRIVER WAS USED IN A COUNTERCLOCKWISE MANNER, WHICH IS NOT CONSISTENT WITH THE INTENDED USE OF THE DEVICE. WHEN LOCKING THE PLATES, THE DRIVER SHOULD BE USED IN A CLOCKWISE MANNER TO LOCK THE PLATES CORRECTLY. IT WAS DETERMINED THAT THE RESISTANCE THAT WOULD HAVE BEEN EXPERIENCED BY USING THE DRIVER IN THE WRONG DIRECTION WOULD CAUSE THE DRIVER TO SNAP, AND IS THE ROOT CAUSE OF THE REPORTED ISSUE. INVENTORY WAS NOT REVIEWED AS THE REPORTED ISSUE OCCURRED DURING THE CASE, AND WAS NOT DUE TO A MANUFACTURING ISSUE. IN CONCLUSION, THE REPORTED ISSUE WAS DETERMINED TO BE AN ISOLATED INCIDENT SINCE THE NON-CONFORMANCE WAS DUE TO SURGICAL TECHNIQUE. THE IMPLANTS BROKE DUE TO MISUSE AND DEVIATION FROM THE SURGICAL TECHNIQUE GUIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF WHILE INSERTING ANODYNE SCREWS INTO THE PLATE. WHEN ATTEMPTING TO TURN THE LOCK WITH THE DRIVER, THE TIP OF THE DRIVER BROKE OFF IN THE HOLE OF THE LOCK. THE PLATE WAS NOT LOCKED BECAUSE THE TIP IS BLOCKING THE HOLE. THERE WAS A DELAY OF 1 HOUR WHILE THE PHYSICIAN ATTEMPTED TO EXTRACT THE BROKEN TIP. THE PHYSICIAN WAS NOT SUCCESSFUL IN THIS ATTEMPT, AND THE TIP REMAINED IN THE LOCK OF THE PLATE. THE PLATE WAS THEN LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928168 ANODYNE ANTERIOR CERVICAL LOCK DRIVER KWQ CORELINK SURGICAL LLC 2020-102 SM091907 M72520201020

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR