BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILOC PERI PLATE INSTRUMENTATION

    MDR report key: 2192020 · Received August 4, 2011

    Report

    Report Number
    1825034-2011-00670
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INSTRUMENTATION WAS RETURNED FOR EVALUATION: CALIBRATED 3.8MM X 250MM DRILL BITS - PART NUMBER 27560 / LOT NUMBER 101844 (QTY. 1) & PART NUMBER 27560 / LOT NUMBER UNKNOWN (QTY. 2). HEX A/O DRIVER 3.5MM - PART NUMBER 27505 / LOT NUMBER 107579 (QTY. 1) & PART NUMBER 27505 / LOT NUMBER 101163 (QTY. 1). FIXED A/O HANDLE - PART NUMBER 22875 / (QTY. 1). RATCHETING A/O HANDLE - PART NUMBER 22880 (QTY. 1). EVALUATION OF THE THREE RETURNED DRILL BIT UNITS CONFIRMED A MANUFACTURING DATE OF (B)(4) 2009 FOR ONE UNIT; TWO OF THE UNITS WERE MANUFACTURED PRIOR TO 2009 HOWEVER DATE COULD NOT BE CONFIRMED AS THE LOT NUMBER WAS NOT PROVIDED. CHANGES TO IMPROVE THE CUTTING PERFORMANCE WERE INITIATED SUBSEQUENT TO THE MANUFACTURE OF THE RETURNED DEVICES. EVALUATION OF THE RETURNED HEX DRIVERS FOUND EVIDENCE THAT THE DRIVERS HAD BEEN MODIFIED; EVALUATION CONFIRMED THE PRESENCE OF A DRILLED HOLE IN THE CENTER OF EACH HEX WHICH DOES NOT MEET BIOMET'S DESIGN SPECIFICATION. EVALUATION OF THE 2 A/O HANDLES FOUND NO EVIDENCE OF TISSUE WITHIN THE HANDLE AS REPORTED. EVALUATION CONFIRMED THE PRESENCE OF A THREAD LOCKING AGENT WHICH IS APPLIED DURING THE MANUFACTURING PROCESS. EVALUATION OF THE 2ND HANDLE COMPONENT DID NOT IDENTIFY ANY ISSUE AND REPORTED PROBLEM WAS UNSUBSTANTIATED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS BEING FILED TO REPORT THE EVENTS AS THEY CAUSED A DELAY TO THE PROCEDURE. NO OBSERVED PRODUCT PROBLEM HAS BEEN IDENTIFIED TO DATE. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A DISTAL FEMORAL PLATE PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, THE SURGEON MADE ATTEMPTS TO UTILIZE THREE 3.8MM DRILL BITS, BUT INITIALLY THEY WOULD NOT PENETRATE THE FAR CORTEX. IT WAS FURTHER REPORTED THAT THE SURGEON HAD DIFFICULTY DRIVING IN SCREWS AS THE DRIVERS BECAME STRIPPED IN THE SCREW HEAD AND THE SCREWS HAD TO BE BACKED OUT MULTIPLE TIMES. THE SURGEON NOTED THE HANDLE OF THE RATCHET USED TO BACK OUT THE SCREWS BECAME LOOSE. THE EVENTS ENCOUNTERED DURING THE PROCEDURE LED TO A DELAY GREATER THAN THIRTY MINUTES. THIS MDR IS BEING FILED DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTILOC PERI PLATE INSTRUMENTATION SURGICAL ORTHOPEDIC INSTRUMENT HWE BIOMET TRAUMA N/A MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R