BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L36 SST

    MDR report key: 3132618 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02419
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    MEASURABLE DIMENSIONS OF THE BROKEN SCREW WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS. RAW MATERIAL CERTIFICATES AND MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH OR STRUCTURAL STABILITY. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. EXCESSIVE APPLIED MECHANICAL FORCE MAY HAVE CAUSED THE BREAKAGE. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, CORTICAL SCREW HEAD BROKE DURING INSERTION. IT WAS REPORTED THE EVENT OCCURRED WHEN THE SURGEON WAS PERFORMING REDUCTION OF FRACTURE ON RIGHT PROXIMAL TIBIA, IMPLANTING PLATE WITH SIX HOLES, AND WHERE THE SCREW HEAD BROKE WHEN IMPLANTING THE SCREW AT THE LAST HOLE. IT WAS ALSO REPORTED THE SURGEON DECIDED TO LEAVE THE SCREW BODY INSIDE THE BONE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A CORTEX SCREW 3.5MM DIAMETER, 36MM LENGTH, SST. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234980 CORTSCR Ø3.5 L36 SST HWC SYNTHES GMBH 7978198

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR