BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCS Ø3 SELF-DRILL CANN L16/5 TAN GOLD

    MDR report key: 3133008 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02889
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K050636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON WAS UNABLE TO USE TWO 3.0MM HEADLESS COMPRESSION SCREWS (HCS). THE SURGEON PREDRILLED THE BONE WITH A 2MM DRILL BIT, MEASURED AND THEN PROGRESSED THE SCREW THROUGH THE FIRST CORTEX. AFTER GAINING COMPRESSION, THE COUNTERSINK SCREWDRIVER WAS INSERTED INTO THE COMPRESSION SLEEVE TO COUNTERSINK THE HEAD OF THE SCREW. THE HEAD ITSELF WOULD NOT COUNTERSINK AND WOULD REMAIN OUT OF THE BONE WITH ALL THREADS SHOWING, MULTIPLE TIMES. ONCE THE COMPRESSION SLEEVE REACHED THE NEAR CORTEX, THE SCREW BEGAN TO ADVANCE OUT OF THE COMPRESSION SLEEVE WITHOUT COUNTERSINKING INTO THE BONE. THIS ADDED AN UNKNOWN AMOUNT OF TIME TO THE SURGERY. THE DEVICE WAS SWAPPED FOR A DIFFERENT PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235110 HCS Ø3 SELF-DRILL CANN L16/5 TAN GOLD HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1