BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREW MEASURING DEVICE FOR 3.5MM AND 4.0MM

    MDR report key: 4180437 · Received October 17, 2014

    Report

    Report Number
    2530088-2014-10311
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 ON (B)(6) 2014 THE DEPTH GAUGE MARKINGS ON A CANNULATED SCREW MEASURING DEVICE WERE WORN AND ILLEGIBLE DURING AN ANKLE OPEN REDUCTION INTERNAL FIXATION PROCEDURE. A BACKUP INSTRUMENT WAS NOT AVAILABLE AND THERE WAS A FIFTEEN MINUTE SURGICAL DELAY. THE SURGEON PLACED AN INCORRECT SCREW DURING THE PROCEDURE REPORTEDLY AS A RESULT OF THE ILLEGIBLE DEPTH GAUGE MARKINGS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663231 CANNULATED SCREW MEASURING DEVICE FOR 3.5MM AND 4.0MM GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 4130569

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR