BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI SELF-DRILLING SCHANZ SCREW 80MM THRD/200MM

    MDR report key: 2851944 · Received November 29, 2012

    Report

    Report Number
    2520274-2012-03443
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    May 29, 2009
    Report Date
    July 8, 2009
    Manufacturer
    SYNTHES
    Product Code
    HWC
    PMA / PMN Number
    K082650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A BROKEN SCHANZ-SCREW. THE SURGEON INSERTED THE NAILS IN THE PROXIMAL METACARPUS REGION. THE SECOND NAIL BROKE WHEN INSERTING IT INTO THE DISTAL REGION. PART OF THE NAIL GOT STUCK INTO THE BOND. THE SURGEON TRIED TO EXTRACT IT USING TWEEZERS WITH MOTOR, BUT COULD NOT GET IT OUT. FOR THIS REASON, AN OSTEOTOMY WAS DONE TO EXTRACT IT. HE THEN PROCEEDED TO HIT THE NAIL WITH A CHISEL. THE SURGEON RETRIEVED A PIECE OF THE NAIL, BUT THE METACARPUS BOND GOT FRACTURED. THE CARBON RODS WERE ALSO TOO SHORT TO NEUTRALIZE THE FRACTURE AND THE DEVICE DID NOT HAVE A ROD TO ROD CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI SELF-DRILLING SCHANZ SCREW 80MM THRD/200MM 6.0MM TI SELF-DRILLING HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention