BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB 1PN/3PK 40X1.3MM KIT

    MDR report key: 4237874 · Received November 7, 2014

    Report

    Report Number
    0001825034-2014-08561
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 10, 2014
    Report Date
    January 8, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO MISUSE OR MISALIGNMENT OF THE RESORBABLE PIN CAUSING THE PIN TO SPLIT DURING INSERTION, AND/OR THE DEVICE WAS NOT INSPECTED FOR WEAR AND DISFIGUREMENT PRIOR TO USE, WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS HAS BEEN REQUESTED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BUNIONECTOMY ON (B)(6), 2014, THE SURGEON HAD THE PIN PREPARED AND WAS PLUNGING THE PIN INTO THE PATIENT WHEN THE PIN SPLIT VERTICALLY. ANOTHER ORTHOSORB PIN WAS USED SUCCESSFULLY AND PATIENT DID NOT RETAIN ANY FOREIGN BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719827 ORTHOSORB 1PN/3PK 40X1.3MM KIT PIN, FIXATION OVZ BIOMET ORTHOPEDICS N/A 482983

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention