BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREWDRIVER FOR DELTA BIO-INT SCREW

    MDR report key: 3924705 · Received July 10, 2014

    Report

    Report Number
    1220246-2014-00119
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE TYPICAL CAUSE(S) OF THIS TYPE OF EVENT INCLUDE FLEXING THE JOINT DURING INSERTION OF THE IMPLANT WITH THE DRIVER ENGAGED OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED OR AS STATED IN THE EVENT DESCRIPTION, INSERTING THE IMPLANT AND DRIVER WITHOUT THE USE OF THE GUIDE WIRE MAY HAVE LED TO IMPROPER ALIGNMENT OR OFF-ANGLE INSERTION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE DURING SURGERY AND REMAINS IN THE PATIENT. THE SURGEON TRIED TO SCREW IN THE SCREWDRIVER A SECOND TIME AS THE SCREW WAS NOT FLUSHED TO THE SURFACE. HE INSERTED IT WITHOUT THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403527 CANNULATED SCREWDRIVER FOR DELTA BIO-INT SCREW ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 401040506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other