BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL, DIAM. 2.0X102MM, WL 50MM, AO-SHAFT

    MDR report key: 2201628 · Received August 4, 2011

    Report

    Report Number
    8010177-2011-00223
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONS REVEALED THAT THE CUTTING EDGES OF THE TIP AND DRILL HELIX WERE DAMAGED. IT WAS DETERMINED THAT THE DRILL HELIX WAS HEAVILY BENT, PLASTICALLY DEFORMED AND UNTWISTED. THE CUTTING EDGES OF THE TIP AND DRILL HELIX SHOWED GROOVES AND PLASTIC DEFORMATIONS RESULTING FROM AN IMPACT WITH A HARD OBJECT AND NOT A BONE. BASED ON INVESTIGATIONS, THE ROOT CAUSE CAN BE ATTRIBUTED TO INAPPROPRIATE USER HANDLING. INDICATIONS FOR MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUES WERE NOT FOUND IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BENT DURING DRILLING. THE SURGEON USED A SPARE PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL, DIAM. 2.0X102MM, WL 50MM, AO-SHAFT IMPLANT HBE STRYKER OSTEOSYNTHESIS FREIBURG NA LC601FAD02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK