BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM

    MDR report key: 3070377 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10744
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE OF A PROXIMAL HUMERUS FRACTURE, DURING SCREW INSERTION INTO THE PLATE, THE SCREWS KEPT SPINNING AND WOULD NOT ENGAGE WITH THE PLATE. THE SURGEON WAS ABLE TO USE A DIFFERENT LENGTH LOCKING SCREW AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS REPORT 2 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171148 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1