BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE

    MDR report key: 3770005 · Received April 24, 2014

    Report

    Report Number
    3003506883-2014-10041
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HWC. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES (STERILE) WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON OTHER HIP (2ND HIP FRACTURE) AND HAD AN OPEN REDUCTION INTERNAL FIXATION WITH CANNULATED SCREWS. THE PATIENT COMPLAINED OF HIP PAIN AT A POST-OP APPOINTMENT WITH THE DOCTOR, WHICH IDENTIFIED THE HELICAL BLADE CUT OUT. AS A RESULT OF THE HELICAL BLADE MIGRATION AND PATIENT PAIN, THE TROCHANTERIC FIXATION NAIL WAS REMOVED. DURING THE TROCHANTERIC FIXATION NAIL REMOVAL, THE SURGEON ATTACHED THE EXTRACTION BOLT TO THE NAIL, UNLOCKED THE MECHANISM WITH THE FLEXIBLE SCREWDRIVER, REMOVED THE HELICAL BLADE WITH THE EXTRACTOR AND HAMMER GUIDE, REMOVED THE LOCKING SCREW WITH HEX SCREWDRIVER, THEN REMOVED THE NAIL WITH THE EXTRACTION BOLT AND HAMMER GUIDE. TROCHANTERIC FIXATION NAIL SUCCESSFULLY REMOVED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. IT WAS REPORTED BY THE SURGEON THAT OVER-COMPENSATION AFTER THE SECOND HIP WAS FRACTURED AND HEALING, MAY HAVE RESULTED IN THE CUT OUT OF THE HELICAL BLADE AND THAT THE FALL OCCURRED PRIOR AND THIS PAIN WAS UNRELATED, THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250201 11.0MM TI HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 6640522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention