BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2902886 · Received December 3, 2012

    Report

    Report Number
    9617083-2012-00033
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    July 25, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: FROM VISUAL EXAMINATION, THE TIP OF BOTH SCREWS HAD FAILED TO ENGAGE AND ADVANCE INTO THE BONE TUNNEL, WHICH RESULTS FROM ATTEMPTED INSERTION OF THE SCREW INTO A TUNNEL TOO SMALL/TIGHT FOR THE DIAMETER OF SCREW. ALSO A PARTICULARLY HARD/DENSE BONE COULD BE A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 2 OF THE SCREWS ATTRIBUTED TO THIS REPORT BROKE DURING RECONSTRUCTION SURGERY OF ANTERIOR CRUCIATE LIGAMENT WITH PATELLAR TENDON. ONE ADD'L SCREW ALSO BROKE DURING THE SAME PROCEDURE, ALREADY REPORTED VIA MDR 9617083-2012-00023. MFR WAS INFORMED REGARDING THE 2 ADD'L SCREWS IN ASSOCIATION WITH THE ORIGINAL REPORT RECEIVED ON (B)(6) 2012, ALTHOUGH THE DEVICES HAD BEEN RECEIVED ON (B)(6) 2012 WITHOUT CLARIFICATION ON THAT DATE. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY USING ANOTHER ITEM AVAILABLE IN THE THEATRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 1111PH1511

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention