BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.75MM COMP RVRS FIXD LOCKNG SCREW 40MM

    MDR report key: 2943975 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00231
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 OR DEVIATION. 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 WAS INCONCLUSIVE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES,"IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY PROCEDURE UTILIZING LOCKING SCREWS ON (B)(6) 2013. UPON INSERTION OF THE LOCKING SCREW, THE HEX STRIPPED AND THE SCREW COULD NOT BE ADVANCED FURTHER. THE SCREW WAS STUCK IN THE BASEPLATE AND PLIERS WERE USED TO REMOVE THE SCREW. ADDITIONAL IMPLANTS WERE USED TO FINISH THE PROCEDURE WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48006 4.75MM COMP RVRS FIXD LOCKNG SCREW 40MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 979510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R