BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL, A/R S2 Ø10X360 MM

    MDR report key: 3161263 · Received June 11, 2013

    Report

    Report Number
    0009610622-2013-00321
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: EVALUATION REVEALED THE S2 FEMORAL NAIL TO BE THE PRIMARY PRODUCT. ALL OTHER MENTIONED PRODUCTS ARE REGARDED TO BE CONCOMITANT ITEMS. THE RETURNED DEVICE MATCHED THE REPORT, AND THE INCIDENT WAS CONFIRMED. INVESTIGATION REVEALED NO DISCREPANCIES IN MATERIAL OF MANUFACTURING. FROM TECHNICAL POINT OF VIEW THE NAIL BROKE IN A FATIGUE MANNER MOST LIKELY CAUSED BY PERMANENT OVERLOAD MAINLY ORIGINATED BY BENDING, AXIAL AND TORSIONAL STRESSES. A STATEMENT FROM A MEDICAL POINT OF VIEW IS NOT POSSIBLE AS NO MEDIAL DATA WAS AVAILABLE.

    Description of Event or Problem · 1

    THE PHARMACIST, REPORTED THE FOLLOWING: " FEMORAL NAIL BROKE. A SURGERY WAS PLANNED TO REMOVE IT".

    Description of Event or Problem · 1

    THE PHARMACIST, REPORTED THE FOLLOWING: " FEMORAL NAIL BROKE. A SURGERY WAS PLANNED TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262189 FEMORAL NAIL, A/R S2 Ø10X360 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K885306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention