BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM

    MDR report key: 5233669 · Received November 18, 2015

    Report

    Report Number
    2520274-2015-17379
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 11, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). (B)(6). THIS DEVICE WAS NOT INITIALLY REPORTED BY THE FACILITY BUT WAS RECEIVED BY THE MANUFACTURER ON NOV 3, 2015 FOR THE INITIALLY COMPLAINED CONDITION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION HAS NOT BEEN COMPLETED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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: DEVICE INVESTIGATION SUMMARY ¿ THE COMPLAINT CONDITION FOR THE THREE (3) 400.833 3MM TITANIUM LOW PROFILE NEURO SCREWS, ONE (1) 4MM TITANIUM LOW PROFILE NEURO SCREWS, TEN (10) 5MM TITANIUM LOW PROFILE NEURO SCREWS, AND FOUR (4) 6MM TITANIUM LOW PROFILE NEURO SCREWS WITH UNKNOWN LOT NUMBERS WAS LIKELY CAUSED BY NOT DRILLING PRIOR TO SCREW INSERTION; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. EIGHTEEN SCREWS WERE RETURNED, SIXTEEN OF WHICH ARE BROKEN AND TWO OF WHICH APPEAR TO BE INTACT. THE PART NUMBERS FOR ONE INTACT 400.834 4MM TITANIUM LOW PROFILE NEURO SCREW AND ONE INTACT 400.836 6MM TITANIUM LOW PROFILE NEURO SCREW CAN BE CONFIRMED THROUGH MEASUREMENT, BUT THE REMAINING BROKEN SCREWS CANNOT. THE SIXTEEN BROKEN SCREWS WILL BE ASSUMED TO BE THE PART NUMBERS AS REPORTED. THE EIGHTEEN TITANIUM LOW PROFILE NEURO SCREWS ARE IMPLANTS ROUTINELY USED IN THE LOW PROFILE NEURO PLATING SYSTEM. THE SCREWS WERE RETURNED AND REPORTED TO HAVE BROKEN DURING INSERTION. THIS CONDITION IS CONFIRMED; TWELVE SCREWS ARE BROKEN ALONG THE SHAFT AND FOUR SCREWS HAVE BROKEN OR ARE SIGNIFICANTLY DEFORMED AT THE VERY DISTAL SELF-DRILLING TIP OF THE SCREW. IT IS LIKELY THAT THE SURGEON DID NOT DRILL PRIOR TO INSERTION WHICH MAY HAVE LED TO THIS COMPLAINT CONDITION. THE BONE WHERE THE SCREWS WERE TO BE INSERTED MAY ALSO HAVE BEEN PARTICULARLY DENSE. THE CONDITION OF THE RETURNED SCREWS IS CONSISTENT WITH ATTEMPTED INSERTION. DEVICE DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT AND ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 3, 2015 FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE EIGHTEEN (18) SCREWS BROKE WHILE BEING INSERTED INTO THE PATIENT. ALL BROKEN SCREW PARTS WERE RETRIEVED FROM THE PATIENT. THE UNKNOWN PROCEDURE WAS PROLONGED 15 TO 20 MINUTES DUE TO THIS INCIDENT. THE PROCEDURE WAS COMPLETED BY USING OTHER SCREWS OF THE SAME SIZE. THERE WAS NO REPORTED HARM TO THE PATIENT AND HE IS DOING WELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763808 TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM BONE PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1