BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI SCREW ANCHORS W/ MAXBRAID NEEDLES

    MDR report key: 2299455 · Received October 18, 2011

    Report

    Report Number
    1825034-2011-00933
    Event Type
    Injury
    Date Received
    October 18, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 27, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    K080088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOTS OF THE TI SCREW ANCHORS WERE USED DURING THIS PROCEDURE. THE INFORMATION FOR THE SECOND ANCHOR DEVICE IS AS FOLLOWS: PART: 902571, LOT: 846380, MANUFACTURE DATE: 06/23/2011, EXPIRATION DATE: 06/30/2016. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "BENDING OR FRACTURE OF THE IMPLANT." EVALUATION OF THE RETURNED DEVICE CONFIRMED THE FRACTURE AND NOTED THE TIP TO BE MISSING. THE FRACTURE ARTIFACTS SUGGEST A POSSIBLE BENDING OVERLOAD FRACTURE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4) 2011. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SPRING LIGAMENT RECONSTRUCTION PROCEDURE UTILIZING TITANIUM SCREW ANCHORS ON (B)(6) 2011. DURING THE PROCEDURE, ONE OF THE ANCHORS FRACTURED DURING INSERTION. THE SURGEON WAS ABLE TO RETRIEVE THE FRACTURED PIECE AND USED A COMPETITOR'S ANCHOR TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN THIRTY MINUTES TO THE PROCEDURE AS A RESULT. SINCE MORE THAN ONE ANCHOR FROM TWO DIFFERENT LOTS WAS USED, IT IS NOT KNOWN WHICH ANCHOR LOT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI SCREW ANCHORS W/ MAXBRAID NEEDLES SCREW, FIXATION HWC BIOMET SPORTS MEDICINE N/A 310260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R