BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI ANGULAR STABEL LOCKING SCREW

    MDR report key: 2944927 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10038
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K090241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING AN ASLS SYSTEM TIBIA EX NAIL PROCEDURE, THE SURGEON INSERTED TWO RESORBABLE SLEEVES OVER THE TWO 5.0MM TI ANGULAR STABLE LOCKING SCREWS. AS THE SURGEON STARTED TO IMPACT GENTLY TO INSERT INTO NAIL, THE TWO SCREWS WOULD NOT ADVANCE WITH GENTLE TAPPING. THE SURGEON USED A DRIVER AND IMPACTED WITH SOME FORCE TO SEAT THE SCREWS. ALL PRODUCTS WERE IMPLANTED; HOWEVER THE PROCEDURE WAS EXTENDED 15-20 MINUTES. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44657 5.0MM TI ANGULAR STABEL LOCKING SCREW HSB SYNTHES GMBH 3238025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RESORBABLE SLEEVE FOR 5.0MM| 5.0 MM TI ANGULAR STABLE LOCKING SCREW