BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT-2.4 CRUCIF SELF-HOLD

    MDR report key: 3211171 · Received July 8, 2013

    Report

    Report Number
    8030965-2013-04237
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMED INVESTIGATION ACCORDING TO OUR MANUFACTURING DOCUMENTS SHOWS NO DEVIATION REGARDING TO OUR GUIDELINES. THE SAME IS TRUE FOR THE HARDENING PARAMETERS, WHICH ARE WITHIN THE REQUIRED TOLERANCES. UNFORTUNATELY WE CAN NOT ELICIT THE EXACT CAUSE, WHICH WAS LEADING TO THIS DAMAGE. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF HIGH TORSION FORCES POSSIBLE IN CONNECTION WITH A NOT COMPLETED INSERTED APPLICATION WAS LEADING TO THIS RESULT. NO PRODUCT FAULT COULD BE DETECTED. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A BLADE OF A SCREWDRIVER BROKE DURING THE OPERATION. THERE WERE NO FURTHER AFFECTED EVENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310758 SCRDRIVERSHAFT-2.4 CRUCIF SELF-HOLD HXX SYNTHES GMBH 3464481

    Patients

    Seq Age Sex Outcome Treatment
    1