BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSREW BIOABSORBABLE INTERFERENCE SCREW 9MM

    MDR report key: 1003809 · Received February 25, 2008

    Report

    Report Number
    1017294-2008-00135
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC HAS NOT RECEIVED THE SCREW TO PERFORM AN EVALUATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE DEVICE HAS BEEN RECEIVED AND EVALUATION. THE INSTRUCTIONS FOR USE PROVIDED WITH THIS DEVICE, WARNS THE USER OF THE FOLLOWING: "IMPROPER ALIGNMENT INCREASES THE RISK OF SCREW BREAKAGE"; "CAREFUL SELECTION OF SCREW SIZE WITH RESPECT TO BONE BLOCK SIZE, SHAPE AND TUNNEL DIAMETER CAN REDUCE THE RISK OF SCREW BREAKAGE", AND "PROPER POSITIONING OF THE GRAFT AND PARALLEL PLACEMENT OF THE GUIDEWIRE PRIOR TO SCREW INSERTION REDUCES THE RISK OF SCREW BREAKAGE." PROPER PREPARATION OF THE REVISED TUNNEL WALL AND THE USE OF A TAP CAN REDUCE THE INCIDENCE OF INTRAOPERATIVE BREAKAGE DURING THE PLACEMENT OF THE BIOSCREW IN REVISION SURGERY. IT WAS REPORTED THAT THE SURGEON DID NOT USE A TAP DURING THIS PROCEDURE, AND THAT HE IS VERY FAMILIAR WITH USING THIS IMPLANT. THIS EVENT (IMPLANT BREAKAGE) OCCURRED WITH TWO OTHER BIOSCREWS DURING THIS SURGERY. IT WAS REPORTED THAT FOLLOWING THE THIRD FAILURE, THE BIOSCREW FROM THE PT'S ORIGINAL SURGERY WAS USED TO COMPLETE THE ACL RECONTRUCTION. THE TWO OTHER EVENTS ARE SUBMITTED UNDER MDR: 1017294-2008-00133 & 1017294-00136. A TWO YEAR REVIEW OF THE PRODUCT HISTORY SHOWS ONE SIMILAR REPORTED PROBLEM. THERE ARE NO REPORTED INJURIES FOR THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THIS BIOSCREW IMPLANT IN AN ACL RECONSTRUCTION, IT BROKE/SNAPPED INTO PIECES AT THE DISTAL END DURING FINAL INSERTION WITH THE DRIVER. IT WAS REPORTED THAT THE PIECES BROKE IN THE SURGICAL SITE AND WERE SUCCESSFULLY RETRIEVED BY USING A GRASPER. THE USER REPORTED, A SURGICAL DELAY WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSREW BIOABSORBABLE INTERFERENCE SCREW 9MM SCREW, FIXATION, BONE MAI CONMED LINVATEC NA BBD41652

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR