BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT LONG 1 #2 BLUE MB

    MDR report key: 3860889 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05399
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL EXAMINATION BY THE DEVELOPMENT ENGINEER OBSERVED THAT ONE OF THE TIPS WAS FRACTURED OFF ON EACH INSERTER, AND THAT ONE OF THE INSERTERS WAS BENT. THE DAMAGE ON THE INSERTERS SUGGESTS THAT THE SURGEON DID NOT HAVE THE GUIDE ALIGNED WITH THE PILOT HOLE DURING INSERTION AND EXCESSIVE FORCE WAS APPLIED TO THE INSERTER WHEN IT DID NOT ENTER THE PILOT HOLE DURING INSERTION. THE SURGICAL TECHNIQUE STATES, ¿MAINTAIN PRECISE GUIDE POSITION OVER THE HOLE AFTER THE REMOVAL OF THE DRILL BIT. WHILE MAINTAINING THE GUIDE POSITION FIRMLY AGAINST THE BONE, INSERT THE JUGGERKNOT LONG SOFT ANCHOR THROUGH THE GUIDE AND INTO THE HOLE.¿ THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, ¿IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE DEVICE CAN LEAD TO FAILURE OF THE DEVICE OR THE PROCEDURE. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICE, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY.¿ AND ¿DO NOT USE EXCESSIVE FORCE WHEN INSERTING THE DEVICE. EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE DEVICE AND/OR ADVERSELY AFFECT ITS PERFORMANCE.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05394, 05399)

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP SCOPE ON (B)(6) 2014. DURING THE PROCEDURE, THE TIP OF THE INSERTER FRACTURED. THE ANCHOR WOULD NOT DEPLOY AND THE TIP REMAINS IN THE BONE. ADDITIONAL ANCHORS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342650 JGRKNT LONG 1 #2 BLUE MB FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET ORTHOPEDICS N/A 718480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R