BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 34MM- FOR IM NAILS

    MDR report key: 2992063 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-10147
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    January 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DATE OF EVENT REPORTED AS APPROXIMATELY 5 MONTHS POST-OP ((B)(6) 2011). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS IMPLANTED WITH A NAIL, HELICAL BLADE AND LOCKING SCREW FOR A RIGHT HIP FRACTURE. POST-OPERATIVELY, THE HELICAL BLADE MIGRATED INTO THE ACETABULUM. THE FEMORAL HEAD APPEARED TO HAVE COLLAPSED AND IMPACTED. THE HELICAL BLADE, NAIL AND LOCKING SCREW WERE REMOVED, AND THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97998 5.0MM TI LOCKING SCREW 34MM- FOR IM NAILS HWC SYNTHES MONUMENT 4920975

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention