BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM DRILL BIT W/STOP STRYKER J-LATCH/125MM

    MDR report key: 3081715 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10805
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 5, 2011
    Report Date
    November 5, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CADAVER LAB WORKSHOP WHILE THE SURGEON WAS USING A DRILL BIT AND COUPLING SCREW FROM THE MATRIXRIB SET, THE DRILL BIT BROKE OFF INTO THE COUPLING SCREW. AT THE CONCLUSION OF THE CADAVER LAB WORKSHOP THE CONSULTANT PLACED THE BROKEN PARTS IN THE DAMAGED GOODS POUCH PROVIDED WITH THE REGIONAL EQUIPMENT SET AND RETURNED THIS SET TO REGIONAL EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184495 5.5MM DRILL BIT W/STOP STRYKER J-LATCH/125MM HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1