BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X30MM

    MDR report key: 3102752 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01346
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 6 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." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01346/ 01347). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE, AS THE SURGEON WAS INSERTING THE TWO SCREWS, BOTH HEADS FRACTURED OFF. THE SCREWS COULD NOT BE RETRIEVED FROM THE PATIENT. AS A RESULT, THE SURGEON USED TWO ADDITIONAL SCREWS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203832 TI LOW PROFILE SCREW 6.5X30MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 632100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S