BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S3 SHOULDER PLATE 4 HOLE RIGHT

    MDR report key: 2988282 · Received March 4, 2013

    Report

    Report Number
    0001825034-2013-00415
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXT
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PMA/510(K) - K111663. MANUFACTURE DATE - SEP 4, 2012.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS ON THE DIFFICULTY REMOVING THE PEG FROM THE PLATE. THE USER DETERMINED THAT THE PLATE AS POSITIONED COULD NOT ACHIEVE THE DESIRED REDUCTION. THE USER THEN PROCEEDED TO REMOVE ALL OF THE PEGS ALREADY IN PLACE AND COULD NOT REMOVE THE MOST PROXIMAL PEG. THE PEG COULD NOT BE REMOVED, CONFIRMING THE COMPLAINT. IT IS NOTED THAT THE PEG SOCKET HAS BEEN DRILLED; THEREFORE A DRIVER COULD NOT BE USED TO VERIFY THAT THE PEG COULD NOT BE REMOVED WITHIN THE CAPABILITY OF THE DRIVER. EVALUATION COULD NOT BE DEFINITIVE RELATIVE TO WHETHER THE PRODUCT WAS DEFECTIVE. THE MOST PROBABLE CAUSE WAS CROSS-THREADING OF THE PEG IN THE PLATE HOLE. THERE IS NO INDICATION OF A SYSTEMATIC MANUFACTURING DEFECT, INCREASING THE LIKELIHOOD THAT THE PRODUCT WAS CONFORMING ON DISTRIBUTION AND THAT THE FAILURE WAS DUE TO CROSS-THREADING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PROXIMAL SHOULDER OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON PUT THE PLATE IN THE BONE, BUT IT DID NOT REDUCE IN THE CORRECT LOCATION. AS A RESULT, THE SURGEON REMOVED THE PLATE AND COMPLETED THE PROCEDURE WITH ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92130 S3 SHOULDER PLATE 4 HOLE RIGHT APPLIANCE, FIXATION LXT BIOMET ORTHOPEDICS N/A RM541B

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R