BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LH 125 DEG 13MM X 420MM NAIL

    MDR report key: 3301319 · Received August 21, 2013

    Report

    Report Number
    0001825034-2013-03285
    Event Type
    Injury
    Date Received
    August 21, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE EXPLANTED DEVICE FOUND EVIDENCE OF FATIGUE FRACTURE OF THE NAIL AND EVIDENCE OF BENDING OVERLOAD OF THE SCREW. EXAMINATION OF RETURNED COMPONENTS FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03285-1/03286-1).

    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 POSSIBLE ADVERSE EFFECTS IT STATES, "CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION" 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03285 / 03286).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP FRACTURE NAILING PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED AFTER RADIOGRAPHS TAKEN ON (B)(6) 2013 REVEALED THE NAIL AND DISTAL LOCKING SCREW HAD FRACTURED. AS A RESULT, A FRAGMENT OF THE FRACTURED SCREW REMAINS IN THE PATIENT. THE NAIL AND ALL OTHER SCREWS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404326 HFN LH 125 DEG 13MM X 420MM NAIL ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A DMGBRZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R