BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 22MM

    MDR report key: 3091390 · Received May 3, 2013

    Report

    Report Number
    1719045-2013-00448
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    February 7, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE RECEIVED FOR STERILIZATION ON 4/08/2013. THE DEVICE WAS NOT RECEIVED FOR EVALUATION UNTIL (B)(4) 2013. SIX SCREWS WERE RECEIVED WITH THE SUBTASKS ASSOCIATED WITH THIS COMPLAINT. EACH WILL BE BAGGED, THE BAGS WILL BE NUMBERED ONE THROUGH SIX, AND EACH ADDRESSED IN TURN. THIS SUBTASK IS ASSIGNED TO SCREW 3. THIS SCREW IS WHOLE AND INTACT. THE LOCKING HEAD, FLUTES, STARDRIVE, AND 3.51MM SHAFT DIAMETER IDENTIFY THIS AS A MEMBER OF THE 212.1XX FAMILY OF SCREWS. THE OVERALL LENGTH CONFIRMS THIS AS A 212.107. THE DRIVE HAS BEEN LIGHTLY DAMAGED, CONSISTENT WITH USE. THE TOP OF THE HEAD IS IN GOOD CONDITION. THE HEAD THREADS HAVE BEEN LIGHTLY DAMAGED IN THE FORM OF LOCALIZED COMPRESSION OF THE MAJOR DIAMETER AT THE SECOND THREAD WHICH DOES NOT AFFECT PROFILE. THE NECK IS IN GOOD CONDITION AS ARE THE SHAFT THREADS, THE FLUTES, AND TIP. THE SPECIFICATIONS THAT WERE CHECKED ARE CONFORMING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTS: PATIENT HAD A SNOWBOARDING INJURY TO THE RIGHT ULNA AND WAS IMPLANTED WITH A PLATE AND SIX SCREWS ON (B)(6) 2012. THE PATIENT WENT TO THE DOCTOR COMPLAINING OF PAIN AND AFTER THE X-RAYS, THE DOCTOR NOTICED THAT THE PLATE WAS BROKEN DOWN THE MIDDLE AT A SCREW HOLE INTO TWO PIECES AND ALL SIX SCREWS WERE INTACT AND NOT BROKEN. THE SURGEON PERFORMED A REVISION PROCEDURE OF AN ORIF OF THE RIGHT ULNA ON (B)(6) 2013, REMOVING THE BROKEN PLATE AND SIX SCREWS AND REPLACING WITH ONE PLATE AND SEVEN SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT NUMBER 4 OF 7 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193994 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 22MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention