BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L16 TAN

    MDR report key: 3091614 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02342
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. UNFORTUNATELY THE LOT NUMBERS ARE UNKNOWN WHAT MAKES IMPOSSIBLE TO CHECK THE MANUFACTURING AND RAW MATERIAL DOCUMENTS. THE SURFACES OF THE CROSS-SECTIONS ARE HOMOGENOUS; NO ANOMALIES OF MATERIALS STRUCTURE WERE FOUND. THEREFORE WE CONSIDER THESE BREAKAGES TO BE CAUSED DURING MECHANICAL OVERLOADING SITUATIONS. IF PATIENTS BONE IS HARD, WE RECOMMEND TAPPING THE HOLE BEFORE INSERTION; EVEN IF A SELF TAPPING TIP WAS CHOSEN FOR THE OPERATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE OPERATION OF A DISTAL RADIUS ON (B)(6) 2013, TWO 1.5 16MM CORTEX SCREWS BROKE DURING INSERTION. THIS OCCURRED WHILE THE SURGEON WAS IMPLANTING A 1.5 T PLATE ON THE ULNA STYLOID. THE SCREW TIP REMAINED IN THE PATIENT. THE BREAKAGE OCCURRED WITH TWO SEPARATE SCREWS IN THE SAME HOLE OF THE PLATE. THE SURGERY WAS COMPLETED WITH SCREWS THROUGH THE OTHER HOLES IN THE PLATE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193903 CORTSCR Ø1.5 SELF-TAP L16 TAN MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1