BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV

    MDR report key: 2879393 · Received December 19, 2012

    Report

    Report Number
    2520274-2012-04157
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    June 29, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K031508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC AND JDQ. 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 CABLE BECAME LOOSE. FIXATION WAS WITH SIX SINGLE LOOP CABLES. DURING SURGERY THERE WERE PROBLEMS WITH THE INSTRUMENT NOT FULLY CUTTING THE CABLE, HOWEVER, THE CRIMPING WENT WELL AND THE FIXATION WAS SOLID. THE SURGEON INFORMED US LATER THAT THE PATIENT HEARD A CRACK WHILE TURNING IN BED. UPON EXAMINATION IT APPEARS THAT FIVE OF THE SIX CABLES HAVE BECOME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV STERNUM GENERAL SST HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention