BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 4326242 · Received December 12, 2014

    Report

    Report Number
    0001825034-2014-09077
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    November 14, 2014
    Report Date
    February 2, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK071704
    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. THE REVIEW OF THE DEVICE HISTORY RECORDS INDICATES NO ABNORMALITIES AND THE DEVICE LEFT BIOMET CONTROL CONFORMING TO PRINT SPECIFICATION.

    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 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. (B)(6). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 5 STATES, ¿CARE IS TO BE TAKEN TO ENSURE ADEQUATE SOFT TISSUE FIXATION AT THE TIME OF SURGERY. FAILURE TO ACHIEVE ADEQUATE FIXATION OR IMPROPER POSITIONING OR PLACEMENT OF THE DEVICE CAN CONTRIBUTE TO A SUBSEQUENT UNDESIRABLE RESULT.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2014, FOUR ANCHORS FAILED. THE MAXBRAID SUTURE BROKE AFTER INSERTION AND NO ANCHORS CAME OUT. SURGEON CHANGED THE PACK OF JUGGERKNOTS HE WAS USING TO ANOTHER 912010 WHICH WORKED FINE FOR THE REST OF THE SURGERY. NEW HOLES NEEDED TO BE DRILLED TO COMPLETE THE PROCEDURE AND THE ANCHORS WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809248 JUGGERKNOT 1.4MM 1 #1 MB 10PK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET ORTHOPEDICS N/A 093500

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention