BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6X110MM , 20MM WL, COLOR DEPTH MARKS

    MDR report key: 3792092 · Received May 6, 2014

    Report

    Report Number
    0008010177-2014-00120
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED RELATED TO STATEMENT THAT THE BORED HOLE OF THE RETURNED DRILL WAS BIGGER THAN THE DIAMETER OF THE DRILL EXPECTED. THE VISUAL INVESTIGATION REVEALED THAT THE DRILL HELIX WAS PLASTICALLY DEFORMED DUE TO AN INAPPROPRIATE USER HANDLING. ACCORDING TO THIS THE TIP OF THE DRILL AND THE CUTTING EDGES WERE DAMAGED AND SHOW NOTCHES AS WELL AS STRONG MARKS OF USAGES RESULTING FROM COLLISION AND FRICTION WITH ANOTHER METAL OBJECT (NO BONE). FURTHERMORE ON THE SURFACE OF THE DRILL HELIX STRONG METAL ABRASIONS ARE VISIBLE RESULTING FROM REPEATED MULTIPLE USES. ACCORDING TO THE IFU TWIST DRILLS ARE FOR SINGLE USE ONLY. SINGLE USE DEVICES CANNOT BE REUSED, AS THEY ARE NOT DESIGNED TO PERFORM AS INTENDED AFTER THE FIRST USAGE IN SURGERY. CHANGES IN MECHANICAL, PHYSICAL OR CHEMICAL CHARACTERISTICS INTRODUCED UNDER CONDITIONS OF REPEATED USE, CLEANING AND RE-STERILIZATION MAY COMPROMISE THE INTEGRITY OF THE DESIGN AND/OR MATERIALS LEADING TO DIMINISHED SAFETY, PERFORMANCE AND/OR COMPLIANCE WITH COMPENDIA SPECIFICATIONS.BASED ON THE INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO AN INAPPROPRIATE USER HANDLING. ACCORDING TO THIS THE DRILL WAS DAMAGED DURING REPEATED MULTIPLE APPLICATIONS (TO NOTICE ¿ DRILL IS SINGLE USE ITEM) WHERE THE DRILL COLLIDED WITH ANOTHER METAL OBJECT LEADING TO THE DAMAGES ON THE CUTTING EDGES AND ON THE TIP OF THE DRILL AND CONSEQUENTLY TO THE PLASTIC DEFORMATION OF THE DRILL HELIX. BECAUSE OF THE PLASTICALLY DEFORMED DRILL HELIX THE DIAMETER OF THE BORED HOLE BECAME BIGGER.INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BSSO CASE, THE DRILL BIT WOULD NOT GRAB THE SCREW AS THE SURGEON FELT IT SHOULD. THE HOLE IN THE SKULL WAS BIGGER THAN THE SCREW THAT WAS BEING PLACED. THE PLATE HAD TO BE REPOSITIONED. PROCEDURE WAS COMPLETED AS SCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BSSO CASE, THE DRILL BIT WOULD NOT GRAB THE SCREW AS THE SURGEON FELT IT SHOULD. THE HOLE IN THE SKULL WAS BIGGER THAN THE SCREW THAT WAS BEING PLACED. THE PLATE HAD TO BE REPOSITIONED. PROCEDURE WAS COMPLETED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270492 1.6X110MM , 20MM WL, COLOR DEPTH MARKS INSTRUMENT HBE STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1