BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 5138356 · Received October 8, 2015

    Report

    Report Number
    0001825034-2015-04238
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 21, 2015
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. IT IS UNKNOWN WHICH INSERTER LED TO INTERVENTION, THEREFORE THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE LOT INFORMATION COULD BE: LOT NUMBER - 310800 OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 242030. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED.¿ 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 PATIENT UNDERWENT A PROCEDURE TO REPAIR THE 5TH LEFT RADIAL COLLATERAL LIGAMENT ON (B)(6) 2015. DURING THE PROCEDURE, ONE INSERTER TIP BENT DURING INSERTION AND ANOTHER TIP FRACTURED OFF DURING INSERTION. AS A RESULT, THE FRACTURED PIECES WERE REMOVED FROM THE PATIENT. THE ANCHOR DID NOT DEPLOY PROPERLY. NO ADDITIONAL DRILLS HAD TO BE DRILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668714 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention