BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 2-0 NDLS

    MDR report key: 3812204 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04089
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 2, 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

    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. 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE COMPONENT INDICATED IMPROPER PLACEMENT/ALIGNMENT WAS USED DURING IMPLANTATION. A CHANGE ORDER HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HAND PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE THE SURGEON EXPERIENCED DIFFICULTY INSERTING THE ANCHOR. THE SURGEON WAS UNABLE TO INSERT THE ANCHOR WITH A SECOND INSERTER. A THIRD INSERTER WAS USED AND THE TIP FRACTURED. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291911 JGRKNT 1.0MM MINI 2-0 NDLS FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 129460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R