BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3232665 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04336
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: CONCOMITANT PRODUCTS: A NON SYTHNES SYSTEM 7 DUAL TRIGGER ROTARY & AN AO LARGE REAMER. ATTACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT THAT TOOK PLACE ON (B)(6) 2013. WHILE THE SURGEON WAS REAMING THE MEDULLARY CANAL FOR AN INTERTROCHANTERIC FRACTURE ON A (B)(6) FEMALE, THE REAMER HEAD BROKE INTO MANY PIECES AT THE DISTAL ASPECT OF THE FEMUR. THE TIP OF THE REAMER SHAFT ALSO WAS DESTROYED. THE SURGEON WAS ABLE TO RETRIEVE MOST OF THE PIECES OUT OF THE CANAL. TWO PIECES REMAIN IMPLANTED. THE EVENT EXTENDED THE SURGERY BY APPROXIMATELY 45 MINUTES. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334028 5.0MM FLEXIBLE SHAFT HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention