BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, MP, CROSS-PIN, DIAM.2.0X4MM,(1/PACKAGE)

    MDR report key: 3203594 · Received July 3, 2013

    Report

    Report Number
    0008010177-2013-00147
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DIMENSIONS OF THE RETURNED SCREWS WERE INSPECTED AND FOUND TO BE INSIDE THE SPECIFICATION. THE VISUAL INVESTIGATION SHOWED THAT EACH CROSS RECESS OF THE SCREW HEADS WERE PLASTICALLY DEFORMED DURING INSERTION AND REMOVAL FROM HIGH AXIAL AND TORSIONAL FORCES. ADDITIONALLY ON THE BACK SIDE OF TWO SCREW HEADS, FRICTION TRACES WERE VISIBLE RESULTING FROM FRICTION WITH PLATES. FURTHERMORE, SCRATCHES AND GROOVES ON THE TOP AND BACK SIDE OF THE SCREW HEAD WERE VISIBLE FROM IMPROPER USE OF TENSION PLIERS. BASED ON THE PERFORMED INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS.

    Description of Event or Problem · 1

    (B)(6) 2013 DURING SURGERY, THE SCREWS SPUN AFTER THE DRILLING WITH THE TWIST DRILL.

    Description of Event or Problem · 1

    (B)(6) 2013 DURING SURGERY, THE SCREWS SPUN AFTER THE DRILLING WITH THE TWIST DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304267 BONE SCREW, MP, CROSS-PIN, DIAM.2.0X4MM,(1/PACKAGE) SCREW HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1