BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS PLASTIC NITINOL DISP X1

    MDR report key: 3082753 · Received April 29, 2013

    Report

    Report Number
    0001825034-2013-01186
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS A DELAY OCCURRED. 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

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EVALUATION OF THE EXPLANTED DEVICE FOUND EVIDENCE THE TWO NEEDLES BENT WHERE THEY WERE DESIGNED TO IF TOO MUCH PRESSURE WAS APPLIED. THE THIRD NEEDLE WHICH HAD THE BUTTON FRACTURED APPEARED TO HAVE BEEN MIS-LOADED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 4 STATES, "DO NOT APPLY EXCESSIVE FORCE TO THE PUSHER ACTUATOR. REPEAT STEP 3A IF NECESSARY TO AVOID EXCESSIVE FORCE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2013. DURING THE PROCEDURE, THREE BIPASS SUTURES WERE USED WITHOUT SUCCESS. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SET AND A BIPASS CLAMP. AS A RESULT, THERE WAS AN HOUR AND A HALF DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185531 BIPASS PLASTIC NITINOL DISP X1 PUSHER, SOCKET HXO BIOMET ORTHOPEDICS N/A 357040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R