BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DSTRADIUS PL 7H HD/2H SHAFT/LT

    MDR report key: 3220867 · Received July 11, 2013

    Report

    Report Number
    8030965-2013-04275
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. AN INVALID LOT NUMBER WAS PROVIDED AND NO PART RECEIVED FOR DHR REVIEW, THEREFORE DHR REVIEW IS DEEMED TO BE INDETERMINATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE SCREW HOLES ARE PARTIALLY DAMAGED, OBVIOUSLY CAUSED POST-MANUFACTURING AS THE ANODIZATION LAYER IS WORN OUT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. INVESTIGATION IS ON-GOING. CORRECTION: THIS IS 2 OF 9 REPORTS FOR THE SAME EVENT, (B)(4). LOT #: CORRECTED FROM 221054 TO 8221054.

    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 IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO THE OPERATING ROOM 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 2 OF 9 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320230 2.4MM TI VA-LCP 2-CLMN VLR DSTRADIUS PL 7H HD/2H SHAFT/LT HRS SYNTHES GMBH 8221054

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention