BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANNULATED SCREW LONG THREAD/36MM

    MDR report key: 2993966 · Received March 8, 2013

    Report

    Report Number
    1719045-2013-00491
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. MANUFACTURING EVALUATION FOUND THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR DIAMETER WERE CHECKED IN THE SECTION OF THREAD WITHOUT DAMAGE AND NO ISSUES WERE FOUND. THE FRONT FLUTES COULD NOT BE VERIFIED DUE TO THE THREAD DAMAGE AT THE TIP. THE BACK FLUTES WERE PRESENT. THE CANNULATION SIZE COULD NOT BE CHECKED BECAUSE THERE IS A GUIDE WIRE STUCK INSIDE OF SCREW. SINCE THERE WERE NO ISSUES ON THE PORTION OF THREAD THAT COULD BE CHECKED AND BECAUSE ALL FEATURES RELEVANT TO THE COMPLAINT COULD NOT BE CHECKED AND BECAUSE NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED SCREW HAS THREAD DAMAGE ON THE TIP END OF THE SCREW. THE SCREW THREADS ARE PEELED AND THERE ARE CUTS IN THE MINOR DIAMETER. THE THREADS NEAR THE SHAFT ARE IN GOOD CONDITION. A GUIDE WIRE IS STUCK INSIDE THE SCREW. THE MATERIAL OF THE DEVICE WAS CHECKED WITH A NITON GUN AND PASSED MATERIAL SPECIFICATION. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR DIAMETER WERE CHECKED IN THE SECTION OF THREAD WITHOUT DAMAGE AND NO ISSUES WERE FOUND. THE FRONT FLUTES COULD NOT BE VERIFIED DUE TO THE THREAD DAMAGE AT THE TIP. THE BACK FLUTES WERE PRESENT. THE CANNULATION SIZE COULD NOT BE CHECKED BECAUSE THERE IS A GUIDE WIRE STUCK INSIDE OF SCREW. THE OPTIONAL STEP OF PRE DRILLING WAS NOT MENTIONED AS BEING DONE DURING THE CASE, WHICH IS RECOMMENDED IN THE TECHNIQUE GUIDE AND INSTRUMENTS ARE PROVIDED IN THE SET TO ACCOMPLISH THIS. ALSO, MULTIPLE QUANTITIES OF 207.736 ARE ABLE TO BE HOUSED IN THE GRAPHIC CASE, SUCH THAT AN IDENTICAL REPLACEMENT COULD BE USED IN CASE THIS HAPPENS. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING SURGERY, THE THREAD COIL PEELED OFF THE STEM OF A 4.0 CANNULATED SCREW BUT WAS STILL CONNECTED TO THE SCREW. THE SURGERY WAS PROLONGED BY A FEW MINUTES. THERE WAS NO ADVERSE EVENT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98616 4.0MM CANNULATED SCREW LONG THREAD/36MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR