BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANNULATED SCREW FULLY THREADED/60MM

    MDR report key: 3072233 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10777
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    November 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DELTOID RUPTURE CASE THE SURGEON WAS INSERTING A TI 4.5 MM CANNULATED FULLY THREADED 60 MM SCREW BY HAND AND GOT DOWN TO THE MEDIAL CORTEX OF THE BONE AND THE HEAD OF THE SCREW SNAPPED OFF. THE SURGEON RETRIEVED THE SHAFT, SELECTED ANOTHER SCREW AND COMPLETED THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175145 4.5MM TI CANNULATED SCREW FULLY THREADED/60MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1