BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSCREW XTRALOK, 9 X 35MM

    MDR report key: 1173366 · Received September 22, 2008

    Report

    Report Number
    1017294-2008-00307
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 5, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC RECEIVED A PORTION OF THE BIOSCREW APPROXIMATELY 10MM IN LENGTH FOR EVAL. A VISUAL EXAMINATION FOUND THAT THE PORTION OF THE SCREW BROKEN WAS AT THE DRIVER END. IN ADDITION, THE EXAMINATION FOUND THE THREADS SEVERELY DAMAGED. THE ROOT CAUSE OF THIS FAILURE WAS UNABLE TO BE DETERMINED. THE INFO FOR USE PROVIDES THE FOLLOWING: CONTRAINDICATIONS: INSUFFICIENT QUANTITY OR QUALITY OF BONE FOR ATTACHMENT. BLOOD SUPPLY LIMITATIONS AND/OR PREVIOUS INFECTIONS, WHICH MAY TEND TO RETARD HEALING. PATIENTS WITH ACTIVE SEPSIS. CONDITIONS WHICH TEND TO LIMIT THE PATIENT'S ABILITY OR WILLINGNESS TO RESTRICT ACTIVITIES OR FOLLOW DIRECTIONS DURING THE HEALING PERIOD. ANY KNOWN ALLERGY OR REACTION TO PLASTIC MATERIAL. WARNINGS AND PRECAUTIONS REGARDING THE RISK OF SCREW BREAKAGE: USE ONLY WITH THE LINVATEC TRI-LOBE DRIVER. THE THREE RADIAL ETCH MARKS ON THE TIP OF THE DRIVER INDICATE FULL INSERTION FOR (20, 25 AND 30MM). FULL INSERTION OF THE BIOSCREW DRIVER WITHIN THE LUMEN OF THE BIOSCREW ABSORBABLE INTERFERENCE SCREW IS MANDATORY FOR PROPER IMPLANT DELIVERY. CARE MUST BE TAKEN TO LINE UP THE LOBES OF THE DRIVER WITH THE SLOTS IN THE SCREW. FAILURE TO ENSURE FULL ENGAGEMENT MAY RESULT IN IMPLANT BREAKAGE. ENDOSCOPIC FEMORAL IMPLANTATION REQUIRES PARALLEL ALIGNMENT OF THE FEMORAL TUNNEL, DRIVER TIP AND BIOSCREW. REPOSITIONING OF THE BIOSCREW REQUIRES COAXIAL DRIVER INSERTION, PROPER ALIGNMENT OF THE SCREWDRIVER LOBES WITH SCREW ALOTS AND FULL DRIVER/SCREW ENGAGEMENT. PROPER POSITIONING OF THE GRAFT AND PARALLEL PLACEMENT OF THE GUIDEWIRE PRIOR TO SCREW INSERTION REDUCES THE RISK OF SCREW BREAKAGE. RISK OF BREAKAGE CAN BE REDUCED BY "NOTCHING" THE TUNNEL AND/OR BY "DILATING" THE BONE BLOCK/TUNNEL WALL GAP WITH THE TIP OF THE BIOSCREW DRIVER AND/OR "TAPPING" THE BONE BLOCK TUNNEL WALL GAP WITH THE LINVATEC BIOSCREW TAP.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THIS SCREW WAS IMPLANTED FOR AN ACL REPAIR IN 2007, AND FOLLOWING THE PT CONTINUED TO HAVE POST-OPERATIVE PAIN. THE SURGEON PERFORMED AN EXPLORATION OF THE KNEE IN 2008, AND FOUND PART OF THE IMPLANTED SCREW BROKEN AND A PORTION OF THE CARTILEDGE ERODED DOWN TO THE BONE. THE SURGEON REMOVED THE BROKEN PART OF THE SCREW AND DEBRIDED THE CARTILAGE. TO DATE, THE STATUS OF THE PT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSCREW XTRALOK, 9 X 35MM BIOABSORBABLE INTERFERENCE SCREW MAI CONMED LINVATEC NA BBD18347

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention