BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 LONG F/MATRIX

    MDR report key: 3193241 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01701
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE INVESTIGATION PERFORMED BASED ON THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE RELEVANT SCREWDRIVER WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. THE BROKEN SURFACE IS HOMOGENOUS WHICH IS IN COMPLIANCE WITH THE MATERIAL. BASED ON THESE FINDINGS THERE WAS NO MANUFACTURING DEFECT. UNFORTUNATELY, THE EXACT CAUSE OF THE DAMAGE CANNOT BE DETERMINED. AT THE STARTING POINT OF THE BREAK YOU CAN SEE THAT ONE EDGE AT THE BROKEN FRAGMENT OF T25 IS DAMAGED. NO PRODUCT ERROR COULD BE DETECTED.

    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. THERE ARE NO NCR DOCUMENTS IN THE DHR; SUBJECT ITEM REPORTED IN THE COMPLAINT CONFORMED TO ALL INSPECTIONS AND CERTIFICATION TESTING. THIS WAS USED WITH THE WRENCH HANDLE. THE FRACTURE OCCURRED PRIOR TO REACHING THE TORQUE 10NM. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER BROKE DURING THE TIGHTENING OF THE CAP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS WAS USED WITH THE WRENCH HANDLE. THE FRACTURE OCCURRED PRIOR TO REACHING THE TORQUE 10NM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294020 SCRDRIVERSHAFT T25 LONG F/MATRIX HXX SYNTHES MONUMENT 6457221

    Patients

    Seq Age Sex Outcome Treatment
    1