BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW DRILL BUSHING STD.

    MDR report key: 5411689 · Received February 4, 2016

    Report

    Report Number
    0001825034-2016-00369
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    December 5, 2015
    Report Date
    February 16, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE COULD NOT CONFIRM THE REPORTED COMPLAINT. THE ROOT CAUSE WAS MOST LIKELY ATTRIBUTED TO THE IMPROPER CLEANING AND STERILIZATION OF THE PRODUCTS AT THE PREVIOUS HOSPITAL; HOWEVER, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 3 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05187-1 / 2016-00368 / 2016-00369 / 2016-00370 / 2016-00371 AND 2016-00372).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INTERNAL HIP FIXATION PROCEDURE ON (B)(6) 2015 DUE TO A FRACTURE AFTER A FALL. INSTRUMENTS WERE BROUGHT FROM ANOTHER HOSPITAL FOR THE PROCEDURE. WHILE ASSEMBLING THE INSTRUMENTS, DRIED BLOOD WAS DISCOVERED. THE SURGEON WAS NOTIFIED OF THE UNSTERILE INSTRUMENTS AND DECIDED TO PROCEED WITH THE CASE WHILE THE INSTRUMENTS WERE FLASH STERILIZED. WHILE WAITING FOR THE INSTRUMENTS TO FINISH STERILIZING, THE PATIENT CODED. THE SURGEON WAS ABLE TO REVIVE THE PATIENT. THE KIT USED DURING THIS PROCEDURE WAS MISSING A LOCKING MECHANISM FOR A THE LAG SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68516 LAG SCREW DRILL BUSHING STD. INSTRUMENT, MANUAL MDM BIOMET ORTHOPEDICS N/A CA85230

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R