BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 3923565 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06079
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    February 7, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE SLEEVES WERE ABLE TO BE MANIPULATED BY HAND, THEREFORE THE ROOT CAUSE WAS DETERMINED TO BE DUE TO SURGEON PREFERENCE. (B)(4). HAS BEEN ADDRESSED FOR THE EVENT. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01673 & 06079 / 06080).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PROXIMAL INTERPHALANGEAL JOINT PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO INSERT A JUGGERKNOT MINI IN THE FIRST HOLE DRILLED; HOWEVER, THE SLEEVE WAS STUCK AND JUGGERKNOT WOULD NOT WORK. A SECOND JUGGERKNOT MINI OF THE SAME LOT WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE SURGEON OPENED ANOTHER JUGGERKNOT MINI AND ATTEMPTED TO INSERT; HOWEVER, THE SLEEVE DID NOT WORK AGAIN AND THE BONE FRACTURED DUE TO A HARD INSERTION. THE SURGEON MADE ANOTHER HOLE AND ATTEMPTED TO INSERT ANOTHER JUGGERKNOT MINI; HOWEVER, BONE HOLE WAS BROKEN DUE TO THE SLEEVE STICKING. THE SURGEON STOPPED USING THE JUGGERKNOT MINI AND IMPLANTED BIONIC BONE AND A K-WIRE IN THE FRACTURED PART. THERE WAS A DELAY IN THE PROCEDURE OF APPROXIMATELY 45 MINUTES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399675 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER FIXATION DEVICE MBI BIOMET ORTHOPEDICS N/A 608390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R