BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 3781644 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03376
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    June 27, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. REVIEW OF THE PRODUCT REVEALS A BROKEN TIP PRONG. THIS IS INDICATIVE OF INCORRECT PLACEMENT OF THE JUGGERKNOT AND/OR INCORRECT ALIGNMENT OF THE JUGGERKNOT WITH THE PREPARED HOLE.

    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 WARNINGS, NUMBER 2 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE DEVICE CAN LEAD TO FAILURE OF THE DEVICE OR THE PROCEDURE." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03374/03376).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SCAPHOLUNATE REPAIR PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE SHAFT OF THE INSERTER WOULD NOT RETRACT FOR THE ANCHOR TO DEPLOY INTO THE PATIENT'S BONE. SUBSEQUENTLY, AN ATTEMPT WAS MADE WITH FOUR SEPARATE JUGGERKNOTS BEFORE THE FINAL JUGGERKNOT WAS SUCCESSFULLY IMPLANTED. THERE WAS A DELAY IN PROCEDURE GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260517 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 224480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R