BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03429

    MDR report key: 3170667 · Received June 14, 2013

    Report

    Report Number
    2520274-2013-03429
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS LOCKING A SCREW DURING A PROCEDURE ON (B)(6) 2013, IT WENT THROUGH A TITANIUM PLATE AT THE MOST DISTAL RADIUS SIDE HOLE. THIS OCCURRED WHILE THE SURGEON USED A STAR DRIVE SCREWDRIVER WITHOUT A LIMITING DEVICE. ADDITIONALLY, A SEPARATE SCREW WOULD NOT LOCK. THE SCREWS WERE POWER DRIVEN AND, AGAINST RECOMMENDATION, LOCKED WITH EXCESSIVE TORQUE. THE PATIENT WAS IMPLANTED WITH A PLATE OF THE SAME SIZE WHICH IS COMPOSED OF STAINLESS STEEL. THE PROCEDURE WAS EXTENDED BY 8 - 10 MINUTES AS A RESULT. THIS REPORT IS FOR THE FIRST UNKNOWN SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270922 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR