BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINLOOP FLEX DISPOSABLE DRILL

    MDR report key: 2900134 · Received December 27, 2012

    Report

    Report Number
    2648666-2012-00368
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DRILLING, IT WAS NOTICED THAT THE TIP OF THE DRILL WAS MISSING. A PROBE WAS USED TO FIND THE TIP STUCK IN THE GLENOID RIM AND WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINLOOP FLEX DISPOSABLE DRILL DISPOSABLE DRILL HTW STRYKER ENDOSCOPY PUERTO RICO 12003AG2

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR