BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CFN Ø12 L380 TAN GREEN

    MDR report key: 2852718 · Received November 30, 2012

    Report

    Report Number
    2520274-2012-03462
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 14, 2009
    Report Date
    November 25, 2009
    Manufacturer
    SYNTHES
    Product Code
    HTY
    PMA / PMN Number
    K954856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT FOR A BONE FRACTURE. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE (B)(6) COMPLAINT HANDLING UNIT REPORTED THAT THE NAIL WAS BROKEN POST-OP. THE PATIENT HAD REMAINED IN BED AND CHAIR FOR 2 AND A HALF MONTHS AFTER SURGERY AND WAS THEN MOBILIZED TO PARTIAL WEIGHT BEARING VIA TOE TOUCH. ON (B)(6) 2009, SHE WENT TO ER WITH LEFT HIP PAIN. THE RADIOLOGICAL EVALUATION REVEALED THE NAIL BREAKAGE AT THE PROXIMAL INTERLOCKING SCREW SITE WITH NO SIGN OF THE FRACTURE HEALING. ALL THE POST OPERATIVE RADIOLOGICAL INVESTIGATIONS SHOWED CORRECT PLACEMENT OF NAIL AND FIXATION OF THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CFN Ø12 L380 TAN GREEN CANNULATED FEMORAL NAIL HTY SYNTHES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention