BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI LOCKING SCREW STARDRIVE 20MM

    MDR report key: 3220866 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04188
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE HRS. THE RESULTS OF THE MANUFACTURING EVALUATION SHOW THAT DUE TO AN UNKNOWN CAUSE THE SCREWS ARE REPORTED TO HAVE MIGRATED FROM THEIR ORIGINAL POSITION. ALL OF THE SCREWS CONFORM TO MATERIAL, LENGTH AND MAJOR THREAD DIAMETERS. THE LOCKING THREADS COULD NOT BE ACCURATELY VERIFIED DUE TO DAMAGE, BUT SEEM TO FUNCTION PROPERLY IN THE GIVEN PLATE. THE INSTRUMENTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE SHAFTS OF ALL 4 SCREWS PASSED THROUGH EACH OF THE INTENDED HOLES OF THE RETURNED 04.111.721 PLATE. THE INVESTIGATOR WAS ABLE TO ENGAGE EACH OF THE VA LOCKING SCREW HEADS INTO THE PLATE THREADED LOCKING HOLES BUT FULL ENGAGEMENT WAS NOT POSSIBLE. THERE IS EVIDENCE HOWEVER, THAT THE VA LOCKING SCREWS (3) WERE ENGAGED AT A VERY EXTREME ANGLE JUDGING FROM THE REMOVAL OF ANODIZATION AND ROLLED OVER THREADS AXIALLY AND APPROXIMATELY 4-5 MM FROM THE SCREWS LOCKING HEAD. REVIEW OF THE RISK ANALYSIS ADDRESSES A POSSIBLE CONTRIBUTING FACTOR FOR IMPROPER PLATE/SCREW INTERFACE HAZARD WHICH MAY LEAD TO THE PLATE BECOMING LOOSE. THE LCP VA PLATE AND VA LOCKING SCREWS ARE DESIGNED TO LOCK WHEN ENGAGED WITHIN A 15 DEGREE RANGE OF THE PLATES SCREW HOLE CENTER LINES AND AS PROVIDED BY USING THE RECOMMENDED DRILL GUIDE. IF THIS RANGE IS EXCEEDED OR DRILL GUIDE IS NOT USED AS RECOMMENDED, AND OR THE PRIMARY REDUCTION IS NOT ADEQUATE, ENGAGEMENT AND LOCKING OF THE SCREW TO THE PLATE MAY NOT BE ACHIEVED AS INTENDED. IF THERE IS A NON-LOCKING OF THE SCREW HEAD TO THE PLATE, MOVEMENT OF THE PLATE MAY OCCUR. IT IS LIKELY THAT INCORRECT SCREW ANGULATION (>15 DEG.) DUE TO IMPROPER USE OF DRILL GUIDE WAS A CONTRIBUTING FACTOR AS EVIDENCED BY THE REMOVAL OF ANODIZATION AND ROLLED OVER MAJOR DIAMETERS OF THE THREE (3) VA LOCKING SCREW THREADS. THE CURRENT CONTROL FOR THIS IS DESCRIBED IN THE SURGICAL TECHNIQUE GUIDE FOR THE SYSTEM. IT IS LIKELY THAT THE IMPLANTATION TECHNIQUE USED WAS INCONSISTENT WITH THE RECOMMENDED METHOD OF USE AS DESCRIBED IN THE 2.4MM VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM TECHNIQUE GUIDE. THE DESIGN WAS EVALUATED AND FOUND TO BE SUITABLE FOR ITS INTENDED USE. CORRECTION: THIS IS 1 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF VARIABLE ANGLE LOCKING SCREWS IN MOLAR DISTAL RADIUS PLATE SUBSIDED OR MOVED. A VARIABLE ANGLE TWO COLUMN PLATE WAS IMPLANTED ON (B)(6) 2013. VARIABLE ANGLE LOCKING SCREWS WERE USED IN THE DISTAL HOLES. UPON FOLLOW UP ON AN UNKNOWN DATE, THE DISTAL VARIABLE ANGLE LOCKING SCREWS HAD SHIFTED PROXIMALLY CAUSING LOSS OF REDUCTION AND RADIAL SHORTING. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. REPORTEDLY, THE SURGEON REMOVED ALL HARDWARE AND THE PATIENT WAS REVISED TO AN EXTERNAL FIXATOR ON THE AFFECTED ARM. THIS IS 1 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321278 2.4MM TI LOCKING SCREW STARDRIVE 20MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention