BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM TI SCREW W/MAX BRAID

    MDR report key: 2973517 · Received February 22, 2013

    Report

    Report Number
    0001825034-2013-00321
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    PK080088
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 1 STATES,"CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IN SOFT TISSUE TO BONE FIXATION IS INCREASED BY THE SELECTION OF THE PROPER TYPE OF IMPLANT." NUMBER 8 STATES, "DO NOT USE EXCESSIVE FORCE WHEN INSERTING SUTURE ANCHORS. EXCESSIVE FORCE (E.G. LONG HARD HAMMER BLOWS) MAY CAUSE FRACTURE OR BENDING OF THE DEVICE. PRIOR TO INSERTION OF THE IMPLANT, PREDRILL, AWL, OR TAP." EVALUATION OF DEVICE FOUND EVIDENCE THAT THE HANDLE SHOWS THAT THE TIP HAS BEEN DEFORMED FROM COMPRESSION AND TORQUE. THE IMPLANT ALSO SHOWS SOME COMPRESSION AND TORSIONAL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A QUADRICEPS REPAIR PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE 6.5 MM TI SCREW ANCHOR AND A 3.5 K-WIRE WERE USED TO BREAK THE CORTEX OF THE BONE. THE SCREW WOULD NOT CATCH AND THE SURGEON USED A SIZE LARGER K-WIRE AND THE SCREW STILL WOULD NOT FIXATE INTO THE PATELLA. THE SURGEON WENT TO A 5.5 SIZE TI SCREW ANCHOR TO COMPLETE THE PROCEDURE. AS A RESULT, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77836 6.5MM TI SCREW W/MAX BRAID SCREW, FIXATION HWC BIOMET SPORTS MEDICINE N/A 034670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R