BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEELER F/SCR-CHANNEL CURV Ø2.3 L275

    MDR report key: 3170054 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03250
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    October 14, 2011
    Report Date
    November 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE INVESTIGATION OF THE SUBMITTED ON/OFF INSTRUMENT ESTABLISHED THAT THE TIP ACTUALLY DID BREAK OFF AND THE ON/OFF SWITCH WAS BENT. INFORMATION FROM THE USER LETS US CONCLUDE THAT THE INSTRUMENT WAS BADLY BENT FROM TOO MUCH MECHANICAL PRESSURE AND BENDING BACK LED TO THE BREAKAGE. NO PRODUCTION ERRORS COULD BE DETERMINED. THE COMPLAINT HAS BEEN DETERMINED TO BE INVALID.

    Description of Event or Problem · 1

    INSTRUMENT GOT BENT DURING SURGERY AND THE TIP BROKE OFF AS IT WAS ATTEMPTED TO BE BENT BACK. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271569 FEELER F/SCR-CHANNEL CURV Ø2.3 L275 HXB SYNTHES GMBH T962565

    Patients

    Seq Age Sex Outcome Treatment
    1