BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED ANGLE DRILL GUIDE 2.3/2.7MM

    MDR report key: 3160470 · Received June 10, 2013

    Report

    Report Number
    0008010177-2013-00113
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INSPECTION OF THE RETURNED 2.3 MM DRILL GUIDE (INNER DIAMETER 1.9 MM) REVEALED THAT IT IS JAMMED WITH THE RETURNED 2.0 MM DRILL. THE DRILL GUIDE HANDLE CONSISTS OF TWO DRILL GUIDES ¿ 2.3 MM DRILL GUIDE MARKED WITH TWO GREEN COLOR RINGS AND THE 2.7 MM DRILL GUIDE MARKED WITH TWO BLACK COLOR RINGS. THE RETURNED BROKEN DRILL WAS MARKED WITH TWO BLACK COLOR RINGS AND THEREFORE THE DRILL IS ONLY TO BE USED IN DRILL GUIDES WITH TWO BLACK COLOR RINGS (2.7 MM DRILL GUIDE) BECAUSE STRYKER MODULES AND COMPONENTS ARE COLOR-CODED AND THEREFORE ONLY FOR USE IN ACCORDANCE TO EACH OTHER AND CORRESPONDING TO THE IFU. THE ROOT CAUSE OF THE JAMMED /BROKEN DRILL IN THE DRILL GUIDE CAN BE ATTRIBUTED TO A USER RELATED ISSUE. THE FIXED ANGLE DRILL GUIDE WAS USED IN WRONG COMBINATION (COLOR-CODED SYSTEM) WITH A DRILL (GREATER DIAMETER THAN INNER DIAMETER OF DRILL GUIDE). NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE DRILL BIT STUCK TO THE DRILL GUIDE AND WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259594 FIXED ANGLE DRILL GUIDE 2.3/2.7MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG Z10

    Patients

    Seq Age Sex Outcome Treatment
    1