BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANNULATED SCREW SHORT THREAD/40MM

    MDR report key: 3041669 · Received April 8, 2013

    Report

    Report Number
    2520274-2013-11076
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING INSERTION OF A 4.0MM CANNULATED SCREW. SURGEON TOOK X-RAYS TO OBSERVE POSITION OF SCREW AND NOTICED THAT THE SCREW HAD NOT ENGAGED INTO THE BONE AS ANTICIPATED. SURGEON REMOVED PROXIMAL PART OF SCREW AND OBSERVED THAT THE THREADING HAD UNWRAPPED FROM THE SCREW. SURGEON WAS ABLE TO REMOVE ENTIRE SCREW INCLUDING UNWRAPPED THREADING. SURGEON USED A DIFFERENT SCREW TO COMPLETE THE PROCEDURE. THE REMOVED SCREW, INCLUDING UNWRAPPED THREADING, WAS GIVEN OVER TO THE FACILITY'S RISK MANAGEMENT DEPARTMENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142967 4.0MM CANNULATED SCREW SHORT THREAD/40MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1