BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHS LAG SCREW L 85 STR

    MDR report key: 2964163 · Received February 15, 2013

    Report

    Report Number
    0001825034-2013-00273
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. 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. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00273 / 00275).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPRESSED HIP SCREW PROCEDURE FOR A FRACTURED NECK OF THE FEMUR ON (B)(6) 2013. DURING THE PROCEDURE, THE LAG SCREW FROM THE CHS PLATE KIT WAS TOO BIG FOR THE PLATE AND DID NOT FIT. A 4-HOLE CHS PLATE WAS OPENED AND ALSO DID NOT FIT THE LAG SCREW FROM THE KIT. A THIRD LAG SCREW WAS OPENED AND AGAIN DID NOT FIT INTO THE PLATE. THE PROCEDURE WAS COMPLETED USING A 6-HOLE CHS PLATE WITH THE LAG SCREW. AS A RESULT THE PROCEDURE WAS DELAYED OVER ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68796 CHS LAG SCREW L 85 STR PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A AT120031

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R