BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM/2.5MM DOUBLE DRILL SLEEVE

    MDR report key: 3082221 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02195
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THERE WAS A STERILIZATION ISSUE WITH DRILL GUIDES FROM THE SYNTHES SMALL FRAGMENT SETS (SSFS). IT IS REPORTED THAT THERE HAS BEEN AN ON-GOING STERILIZATION ISSUE WITH THESE GUIDES INVOLVING POSSIBLE FINISH DEGRADING OR SOME OTHER FINISH ISSUE. IT WAS REPORTED THAT THIS HAS HAPPENED MORE THAN ONCE AND THAT THE DRILL GUIDES WERE OVER 20 YEARS OLD. NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 7 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183589 3.5MM/2.5MM DOUBLE DRILL SLEEVE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1