BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 42MM

    MDR report key: 2896655 · Received January 4, 2013

    Report

    Report Number
    1719045-2013-00025
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES ONE SCREW HEAD WAS RETURNED.. THE PART NUMBER SUPPLIED WAS 214.842. THE HEAD DIAMETER AND SHAPE SUGGESTS THAT THIS MAY INDEED BE OF THE 214.8XX FAMILY OF PARTS WHICH ARE 4.5MM SELF-TAPPING CORTEX SCREWS. IF SO, THIS SCREW WAS MADE PRIOR TO 15NOV10 AS EVIDENCED BY THE LASER ETCH MARKINGS. IT HAS BEEN BROKEN OFF AT THE BEGINNING OF THE FIRST THREAD. THERE ARE NO THREADS TO EXAMINE. THE DRIVE HAS BEEN MODERATELY DAMAGED WITH METAL DISPLACEMENT EVIDENT AT THE UPPER PORTION OF THE DRIVE. THE TOP OF THE HEAD IS RELATIVELY FREE OF MARKS/DAMAGE. THERE IS A SPIRALING MARK OF GALLING/DISPLACED MATERIAL ON THE BOTTOM OF THE SCREW BEGINNING AT THE NECK AND ENDING AT THE BAND. DUE TO THE TYPE AND EXTENT OF DAMAGE INCURRED AND ALSO BECAUSE NO LOT NUMBER WAS SUPPLIED, A FINITE ANALYSIS WAS NOT POSSIBLE. MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    DURING A DHS HIP SCREW PROCEDURE, THE SCREW HEAD SHEARED OFF. THE SCREW AND PLATE WAS IMPLANTED AS THE SURGEON WAS FINAL TIGHTENING, THE SCREW HEAD SHEARED OFF. THE HEAD OF THE SCREW WAS RETRIEVED FROM THE WOUND. AN X-RAY WAS TAKEN TO ENSURE THERE WERE NO FRAGMENTS IN THE PATIENT. THE REMAINDER OF THE SCREW IS STILL IMPLANTED IN THE PATIENT BONE. THE SURGEON DID NOT ATTEMPT TO REMOVE THE SCREW AND REPLACE IT. THE SURGEON PLACED CERCLAGE WIRE AROUND THE AREA WITH THE BROKEN SCREW HEAD TO REINFORCE THE IMPLANT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4058 4.5MM CORTEX SCREW SELF-TAPPING 42MM 4.5MM CORTEX SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention PLATE