BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 3141320 · Received June 3, 2013

    Report

    Report Number
    0008031020-2013-00172
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT A THIN WIRE OF METAL FROM THE SCREW BEGINS TO SHAVE OFF COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE WIRE CAME OFF BECAUSE THE USER INSERTED THE SCREW IN A WRONG POSITION. PLEASE FOLLOW EXACTLY THE CORRESPONDING OP-TECH TO AVOID DAMAGING THE SCREW. WHEN USING THE DRILL GUIDE THE THREAD OF THE SCREW CANNOT TOUCH THE PLATE AND THEREFORE THE SCREW CANNOT BE DAMAGED BY THE PLATE. ONE POSSIBILITY IS THAT THE SURGEON WAS DRILLING WITHOUT A DRILL GUIDE AND THEREFORE THE HOLE FOR THE SCREW WAS DECENTERED. THEN THE SURGEON WAS INSERTING THE SCREW IN THE DECENTERED HOLE THE SCREW WAS DAMAGED BY TOUCHING THE PLATE. THE WIRE HAS TWO COLORS AND THE GOLDEN COLOR (COLORED WITH ANODISATION) IS FROM THE SCREW SURFACE. THE SILVER COLOR IS FROM THE RAW MATERIAL OF THE SCREW. WE ASSUME THAT THE WIRE CAME FROM THE SCREW THREAD AND NOT FROM THE PLATE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    SURGEON WAS INSERTING A 3.5MM NON-LOCKING SCREW INTO THE OBLONG HOLE OF A 6 HOLE MEDIAL VARIAX ELBOW PLATE ANGLED IN A PROXIMAL DIRECTION, UPON INSERTING THE SCREW A THIN WIRE OF METAL FROM THE PLATE BEGIN TO SHAVE OFF THE PLATE AS THE SCREW WAS INSERTED.

    Description of Event or Problem · 1

    SURGEON WAS INSERTING A 3.5MM NON-LOCKING SCREW INTO THE OBLONG HOLE OF A 6 HOLE MEDIAL VARIAX ELBOW PLATE ANGLED IN A PROXIMAL DIRECTION, UPON INSERTING THE SCREW A THIN WIRE OF METAL FROM THE PLATE BEGIN TO SHAVE OFF THE PLATE AS THE SCREW WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244704 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT LXH STRYKER OSTEOSYNTHESIS-SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other