BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI W/ MAXBRAID NEEDLES

    MDR report key: 4792221 · Received May 22, 2015

    Report

    Report Number
    0001825034-2015-02182
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK012503
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 EXCESSIVE FORCES DURING IMPLANTATION, MORE SPECIFICALLY TORSIONAL OVERLOAD WHILE INSERTING THE ANCHOR INTO THE BONE.

    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 POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "BENDING OR FRACTURE OF THE IMPLANT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROSCOPY ON (B)(6) 2015. DURING THE PROCEDURE, THE SUTURE ANCHOR FRACTURED IN THE PATIENT. THE FRACTURED FRAGMENT WAS REMOVED AND ANOTHER ANCHOR WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335882 5.0MM TI W/ MAXBRAID NEEDLES FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 358300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention