BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3191891 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03339
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE THREADED TIP IS BROKEN OFF. FURTHER INVESTIGATION SHOWED CONFORMITY OF BOTH ARTICLES TO OUR SPECIFICATIONS AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. NO PRODUCT OR MATERIAL RELATED FAULT WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART WAS BROKEN AT THE TOP DURING THE OPERATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290187 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES GMBH 2523116

    Patients

    Seq Age Sex Outcome Treatment
    1