BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE, SURGICAL, INSTRUMENT

    MDR report key: 3864152 · Received June 10, 2014

    Report

    Report Number
    2520274-2014-11744
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 1 GUIDE SLEEVE, PART AND LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON WAS USING THE DRILL BIT IN QUESTION DURING A HUMERAL SURGICAL NECK FRACTURE CASE. THE SURGEON WAS DRILLING SCREW HOLES FOR DISTAL LOCKING WITH THE DRILL BIT, BUT ENCOUNTERED INTERFERENCE WITH THE NAIL AT THE PROXIMAL HOLE. THE SURGEON CORRECTED THE DIRECTION OF THE DRILL BIT BY PUSHING THE SLEEVE AND FINISHED DRILLING; THE SCREW INSERTION WAS COMPLETED WITH A MINOR INTERFERENCE. THIS RESULTED IN A TWO MINUTE DELAY, NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR 1 GUIDE SLEEVE, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338426 GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1