BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02920

    MDR report key: 3132017 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02920
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: HRS. ADDITIONAL INFORMATION: IT IS UNKNOWN WHICH DEVICE THE CHIP CAME FROM. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. AS NO PART OR LOT NUMBER WAS GIVEN FOR THE DEVICE RETURNED, A DEVICE HISTORY RECORDS REVIEW CAN NOT BE COMPLETED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. VISUAL INSPECTION OF THE METAL PART INDICATES THAT THIS MUST BE SHAVING FROM A LOCKING SCREW WHICH SHARED OFF DURING INSERTION. NO FURTHER INVESTIGATION IS POSSIBLE. WE ARE NOT ABLE TO IDENTIFY ANY ROOT CAUSE FOR THE REPORTED PROBLEM. MOST PROBABLY REASON MAY BE STRONG CONTACT WITH THE PLATE DURING INSERTION PROCEDURE. PLEASE NOTE, THE 2.7MM VA LOCKING SCREW IS NOT COMPATIBLE WITH TWO-COLUMN PLATE. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A SURGEON IN (B)(4) REPORTED: DURING SURGERY FOR A DISTAL RADIUS FRACTURE, THE SURGEON INSERTED AND LOCKED 4 VA LOCKING SCREWS IN DISTAL HOLES BY GUIDING BLOCK, AND FIXED BY DRIVER WITH TORQUE LIMITER. SECOND, HE INSERTED AND LOCKED 2.7MM 2 CORT.SCREWS IN PROXIMAL SHAFT HOLES BY DRIVER WITH TORQUE LIMITER. THIRD, HE INSERTED AND LOCKED 2.7MM 2 VA LOCKING SCREWS IN PROXIMAL VA HOLES BY TORQUE LIMITER, BY THIS TIME, ALL SCREWS COULD BE LOCKED. AND THEN HE TOOK OFF GUIDING BLOCK FIXED VA LOCKING SCREWS BY DRIVE WITH TORQUE LIMITER JUST IN CASE. HOWEVER, VA LOCKING SCREW IN DISTAL ROW MOST STYLOID SIDE HAD NOT STOPPED ROTATION. FINALLY THIS SCREW WAS PENETRATED IN HOLE. HE FOUND A METAL PART LIKE THREAD WHICH WAS ADHERED IN THE PATIENT BODY. SURGERY WAS PERFORMED BY GLOBAL TECHNICAL METHOD. HE CHOSE FIXED MODE, AND USED TORQUE LIMITER 0.8NM IN LOCK. THE METAL CHIP IS BEING RETURNED. THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236636 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR