BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-07272

    MDR report key: 3464924 · Received November 12, 2013

    Report

    Report Number
    2520274-2013-07272
    Event Type
    Injury
    Date Received
    November 12, 2013
    Report Date
    October 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS REPORT IS ON AN UNKNOWN CSLP PLATE, PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT A PART NUMBER THE 510K NUMBER CANNOT BE PROVIDED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT. TWO TITANIUM VECTRA-T PLATES, TWO-LEVEL (PART# 450.563 LOT#S 3400258, 8028374) AND ONE 4.0MM VARIABLE ANGLE SCREW WERE RETURNED FOR THE ELGILOY WISHBONE CLIP REPORTEDLY BREAKING DURING FINAL TIGHTENING AND SCREW INSERTION. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE PLATES ARE DESIGNED TO UTILIZE VARIABLE AND FIXED ANGLE SCREWS. THE VARIABLE ANGLE SCREWS HAVE A 28° RANGE IN THE CRANIAL-CAUDAL DIRECTION AND 14° RANGE IN THE MEDIAL-LATERAL DIRECTION. THE WISHBONE CLIPS ARE MADE FROM ELGILOY, ASTM F-1058 GRADE 1 AND ARE REQUIRED TO HAVE A MINIMUM TENSILE STRENGTH OF 1138 MPA. THIS ENSURES BENDING OR BREAKING OF THE CLIPS DOES NOT OCCUR DURING SCREW INSERTION. THE 4.0MM VARIABLE ANGLE SCREW LOCKED TO ONE OF THE RETURNED PLATES SUGGESTS THAT SCREW ORIENTATIONS OUTSIDE OF THE NOMINAL TRAJECTORY WERE PURSUED. THE BREAKING AND DAMAGING OF THE CLIPS REPORTED MAY BE DUE TO SCREW INSERTIONS AND FINAL TIGHTENING AT ANGLES OUTSIDE OF THE RANGE THE PLATES ARE DESIGNED FOR. THIS CAN OCCUR WHEN THE SCREW ARE INSERTED AT SHARP ANGLES IN THE MEDIAL-LATERAL DIRECTION WHERE THE DESIGNED RANGES ARE SMALLER COMPARED TO THE CRANIAL-CAUDAL DIRECTION AND THE WISHBONE CLIPS PROTRUDE FURTHER INTO THE SCREW HOLE. REVIEW OF THE CLIPS FOUND THE DESIGN TO BE ADEQUATE FOR THEIR INTENDED USE. THE COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581116 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention