BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW GUIDE SLEEVE GAMMA3 ?25X245MM

    MDR report key: 2942315 · Received January 8, 2013

    Report

    Report Number
    9610622-2013-90018
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. WENT TO ATTACHED LAG SCREW (IMPLANT) TO THE LAG SCREWDRIVER AND HAD DIFFICULTY GETTING THEM TO JOIN. UPON FURTHER EXAMINATION, HE STATED THAT THE TEETH ON THE DRIVER WERE BENT. IN ADDITION, THE SHAFT OF THE LAG SCREWDRIVER WAS BENT CAUSING AN IMPINGEMENT OF THE LAG SCREW DRIVER AND THE LAG SCREW GUIDE SLEEVE. SURGEON ALSO HAD DIFFICULTY TAKING OFF THE LAG SCREW DRIVER ONCE THE IMPLANT WAS PLACED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10298 LAG SCREW GUIDE SLEEVE GAMMA3 ?25X245MM INSTRUMENT LXH STRYKER TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other