BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® COUPLING SCREW

    MDR report key: 3051869 · Received April 10, 2013

    Report

    Report Number
    2530088-2013-10417
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    October 10, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE INFORMATION CONTAINED IN THIS REPORT IS INSUFFICIENT TO DETERMINE THE CAUSE OF THE INSTRUMENT FAILURE. THE INSTRUMENT DESIGN INCLUDING CROSS SECTION ANALYSIS WAS REVIEWED AND DETERMINED TO MEET THE INTENDED USE. THEREFORE THIS COMPLAINT IS INDETERMINATE. PLACEHOLDER.

    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCOUNTS HAS A DHS/DCS COUPLING SCREW WITH A BENT TIP AND ANOTHER ONE WITH A BROKEN TIP. THE BROKEN TIP OCCURRED DURING A PROCEDURE. ACCOUNT REPORTS THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT AND DISCARDED BY THE OR STAFF.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4). THE PRODUCT REPORTED TO HAVE BROKEN WAS THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148328 DHS®/DCS® COUPLING SCREW LXH SYNTHES BRANDYWINE 6379907

    Patients

    Seq Age Sex Outcome Treatment
    1