BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL STOP

    MDR report key: 3782115 · Received April 30, 2014

    Report

    Report Number
    2530088-2014-10091
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THERE WERE NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE DRILL STOP WAS RECEIVED INTACT CONTAINING SCRATCHES AND ROLL MARKS CONSISTENT WITH REGULAR USE. THE DEVICE WAS MANUFACTURED IN JUNE 2008 AND IS SIX YEARS OLD. THE DEVICE IS RECOMMENDED FOR USE ALONG WITH A COMPANION STEP DRILL IN TROCHANTERIC FIXATION NAIL APPLICATIONS WHERE DENSE BONE IS ENCOUNTERED. DURING THIS EVALUATION, THE RETURNED DRILL STOP WAS ASSEMBLED WITH A STEPPED 6MM/10MM DRILL BIT (PART #357.403 LOT # PE01778). THE RETURNED DRILL STOP HELD PERFECTLY WHEN CONSIDERABLE LINEAR FORCE WAS APPLIED IN BOTH DIRECTIONS. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THIS COMPLAINT DESCRIPTION IS UNCONFIRMED FOR THIS DEVICE. 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

    (B)(6) REPORTED THE FOLLOWING: A COMPLAINT WAS REPORTED AGAINST A DRILL STOP. AN INTRAMEDULLARY NAIL FEMUR WAS BEING PERFORMED AND THE DRILL STOP WOULD NOT LATCH TO THE DRILL BIT; THE SURGEON HAD TO BE CAREFUL WHILE DRILLING BECAUSE THE CALIBRATION COULD NOT BE CONTROLLED. THE DEFECTIVE DRILL STOP WAS NOTICED PRIOR TO SURGERY, BUT THE SURGEON ELECTED TO UTILIZE THE DRILL STOP. THERE WAS NO DELAY IN SURGERY. THE PATIENT WAS STABLE AFTER SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260966 DRILL STOP GUIDE FZX SYNTHES BRANDYWINE 5736918

    Patients

    Seq Age Sex Outcome Treatment
    1