BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL, A/R S2 Ø11X400 MM

    MDR report key: 3020069 · Received March 25, 2013

    Report

    Report Number
    0009610622-2013-00161
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 28, 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
    OTHER HEALTH CARE PROFESSIONAL

    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 SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE EVENT WAS CONFIRMED. NO MANUFACTURING FAULTS FOUND. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE. WITH RESPECT TO THE INFORMATION AVAILABLE WE CONCLUDE THAT THE NAIL BROKE DUE TO OVERLOADING AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 23 MONTH. NO MEDICAL INFORMATION WAS PROVIDED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NONCONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE RESIDENT REPORTED THE FOLLOWING EVENT, "THE PATIENT WAS IMPLANTED WITH A S2 NAIL IN (B)(6) 2011. A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2013 BECAUSE THE NAIL FRACTURED. THE BROKEN NAIL WAS EXPLANTED AND REPLACED BY ANOTHER ONE."

    Description of Event or Problem · 1

    THE RESIDENT REPORTED THE FOLLOWING EVENT, "THE PATIENT WAS IMPLANTED WITH A S2 NAIL IN (B)(6) 2011. A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2013 BECAUSE THE NAIL FRACTURED. THE BROKEN NAIL WAS EXPLANTED AND REPLACED BY ANOTHER ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121928 FEMORAL NAIL, A/R S2 Ø11X400 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K272142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R