BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 32MM

    MDR report key: 3080560 · Received April 26, 2013

    Report

    Report Number
    2520274-2013-02132
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    RETRACTING DHR RESULTS AS PREVIOUSLY REPORTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY FOR THE REMOVAL OF A TIBIAL NAIL WAS MADE NECESSARY BY A NON-UNION AND FIBROUS GROWTH AROUND A LINE OF FRACTURE. AN X-RAY ON AN UNKNOWN DATE REVEALED THE NON-UNION. DURING SURGERY, THE 11MM X 375MM TIBIAL NAIL WAS REMOVED ALONG WITH THREE 5MM LOCKING SCREWS. THEY WERE REPLACED WITH A 12MM X 375MM TIBIAL NAIL AND THREE 5MM LOCKING SCREWS. DURING THE REVISION SURGERY, THE SURGEON USED A 3.5 CORTICAL BLOCKING SCREW TO INSERT THE NEW 12MM TIBIAL NAIL. THE BLOCKING SCREW WAS NICKED AND A FRAGMENT CAME OFF DURING REAMING. AN X-RAY ON THE DAY OF SURGERY REVEALED THAT THE PIECE WAS SUCCESSFULLY RETRIEVED. THIS IS 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181277 3.5MM CORTEX SCREW SELF-TAPPING 32MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR