BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQUE LIMITING ATTACHMENT

    MDR report key: 3725272 · Received April 3, 2014

    Report

    Report Number
    8030965-2014-10080
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DISCONNECTING SLEEVE WAS DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED THAT THE DEVICE APPEARED TO HAVE BEEN MISHANDLED OR DROPPED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ¿QUICK RELEASE WAS STICKING¿ ON THE TORQUE LIMITING ATTACHMENT DEVICE. ACCORDING TO THE REPORTER THE ¿DRILL BITS¿ WERE FALLING OUT OF THE DEVICE. IT WAS FURTHER CLARIFIED THAT THE DRILL BIT USED WAS LOOSE; THE SURGEON TRIED TO DRILL A HOLE IN THE BONE, HOWEVER, THE DEVICE WOULD NOT HOLD THE DRILL BIT. THE REPORTER ALSO STATED THAT DURING DRILLING, THE DRILL BIT BECAME STUCK IN THE BONE AND THE DRILL BIT HAD TO BE MANUALLY PULLED FROM THE BONE. THERE WAS A FORTY-FIVE MINUTE DELAY IN SURGERY AS THE PROCEDURE HAD TO BE COMPLETED BY HAND. THE REPORTER STATED THAT A SPARE DEVICE WAS USED TO PUSH THE SCREW HALFWAY INTO THE BONE. THE SURGEON THEN HAD TO USE A HAND TECHNIQUE TO MANUALLY SCREW THE DRILL BIT INTO THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS A CANINE. THE REPORTER STATED THAT THE POST-OP CONDITION OF THE PATIENT WAS NORMAL. THE REPORTER CLARIFIED THAT THE EVENT OCCURRED DURING THE MONTH OF FEBRUARY 2014; HOWEVER, THE EXACT DATE WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202317 TORQUE LIMITING ATTACHMENT MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF 1288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRILL BIT DEVICE