BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 3573284 · Received January 14, 2014

    Report

    Report Number
    0001825034-2014-00433
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    December 13, 2013
    Report Date
    March 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    MANUFACTURING HISTORY NECESSARY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THERE WERE SPIRAL ABRASIONS, SCRATCHES & GOUGES LEADING UP TO THE FRACTURE. THE SPIRAL PATTERN SUGGESTS THE SHAFT CONTACTED A HARD METAL OBJECT DURING ROTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BUNIONECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE ORTHOSORB PIN FRACTURED. ANOTHER PIN WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36746 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION OVZ BIOMET ORTHOPEDICS N/A 389436

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention