BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T6 HEXALOBULAR DRIVE AO 2.0MM

    MDR report key: 4637893 · Received March 27, 2015

    Report

    Report Number
    0001825034-2015-01172
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 3, 2015
    Report Date
    May 7, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A PROCEDURE TO ISOLATE A RADIAL NECK FRACTURE ON (B)(6) 2015. DURING THE PROCEDURE, THE SURGEON IMPLANTED A RADIAL RIM PLATE AGAINST HIS PREFERENCE AS THE RIM PLATE WAS LONG AND SAT ON THE RIM OF THE PATIENT'S NATURAL RADIUS. SHORTER THAT THE RADIAL RIM PLATES. ALSO, DURING THE PROCEDURE, THE HEX SCREWDRIVER TIP FRACTURED OFF INTO THE HEAD OF A SCREW. THE TIP OF THE SCREWDRIVER REMAINS IN THE SCREW HEAD, WHICH IS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A PROCEDURE TO ISOLATE A RADIAL NECK FRACTURE ON (B)(6) 2015. DURING THE PROCEDURE, THE SURGEON IMPLANTED A RADIAL RIM PLATE AGAINST HIS PREFERENCE AS THE RIM PLATE WAS LONG AND SAT ON THE RIM OF THE PATIENT'S NATURAL RADIUS. SHORTER THAT THE RADIAL RIM PLATES. ALSO, DURING THE PROCEDURE, THE HEX SCREWDRIVER TIP FRACTURED OFF INTO THE HEAD OF A SCREW. THE TIP OF THE SCREWDRIVER WAS ABLE TO BE RETRIEVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT ANY OTHER COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A RADIAL NECK FRACTURE PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE HEX SCREWDRIVER TIP FRACTURED IN THE HEAD OF SCREW AND NEEDED TO BE RETRIEVED FROM THE PATIENT. IT WAS ALSO NOTED THAT THE RADIAL NECK PLATE WAS SHORTER THAN THE RADIAL RIM PLATE THEREFORE A LONGER RIM PLATE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205209 T6 HEXALOBULAR DRIVE AO 2.0MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability