BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 36MM

    MDR report key: 3070565 · Received February 1, 2013

    Report

    Report Number
    1719045-2013-10005
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    April 21, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. VISUAL INSPECTION OF THE SCREW REVEALED SEVERE DAMAGE TO THE THREADS WITH FLATTENED AND DEEP MARKINGS. THE TOP OF THE SCREW HEAD HAD INDICATIONS OF MARKS AND SCRATCHES. IN ADDITION SLIGHT SCRATCHES WERE NOTED ON THE TROCAR TIP. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. IMPLANT DATE IS REPORTED AS UNKNOWN DAY IN 2009.

    Description of Event or Problem · 1

    PT IMPLANTED WITH NAIL, HELICAL BLADE AND 2 LOCKING SCREWS IN 2009 FOR A HIP FRACTURE FIXATION. CEMENT WAS ADDED TO HELICAL BLADE DURING ORIGINAL PROCEDURE. PT COMPLAINED OF HIP PAIN ON AN UNK DATE. X-RAYS SHOWED COLLAPSED HIP AND BENT NAIL. SURGEON WAS UNABLE TO DETERMINE, IF NAIL WAS BROKEN WITH INITIAL X-RAY. PT WAS REVISED ON (B)(6) 2011. SURGEON'S INTENT OF REVISION WAS TO REMOVE HARDWARE AND REVISE TO ANOTHER DEVICE. DURING REVISION IT WAS NOTED THE BONE WAS INFECTED AND THE NAIL WAS BROKEN. NAIL, HELICAL BLADE AND 2 LOCKING SCREWS WERE REMOVED. DUE TO INFECTION, SURGEON REVISED PT TO SPACERS AND COMPLETED PROCEDURE. PT HISTORY - AML AND MASTECTOMY DUE TO BREAST CANCER. THIS COMPLAINT IS ON THE 2ND TI 5.0MM LOCKING SCREW. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45815 5.0MM TI LOCKING SCREW 36MM HWC SYNTHES (USA) MONUMENT 5736890

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention NAIL| HELICAL BLADE| 5.0MM TI LOCKING SCREW 38MM