BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/75MM

    MDR report key: 4256726 · Received November 17, 2014

    Report

    Report Number
    3003506883-2014-10145
    Event Type
    Injury
    Date Received
    November 17, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ORIGINAL IMPLANT DATE UNKNOWN. (B)(4) REQUIRED INTERVENTION OF THE REMOVAL OF THE ORIGINAL INTACT HARDWARE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 5240190 OF DHS/DCS ONE-STEP LAG SCREW 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (5074213) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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 THAT THE PATIENT HAD AN INTERTROCHANTERIC FRACTURE ON UNKNOWN DATE AND ONE DYNAMIC HIP SYSTEM (DHS) PLATE, ONE LAG SCREW, ONE COMPRESSION SCREW AND THREE CORTEX SCREWS WERE IMPLANTED. THE FRACTURE REPORTEDLY HAD HEALED. ON AN UNKNOWN DATE, THE PATIENT'S GREATER TROCHANTER RE-FRACTURED DUE TO AN UNKNOWN REASON AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. TWO 7.3 MM CANNULATED SCREWS WERE IMPLANTED. ALL THE HARDWARE FROM THE ORIGINAL SURGERY WAS EXPLANTED INTACT. THERE IS NO ALLEGATION AGAINST THE EXPLANTED DEVICES AND THEY WERE EXPLANTED ONLY TO PUT IN THE NEW HARDWARE FOR THE REVISION SURGERY. THE PATIENT OUTCOME WAS FINE, THERE WAS NO TIME DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742435 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/75MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES ELMIRA 5240190

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention