BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP® DHHS(TM) COUPLING SCREW 324MM

    MDR report key: 2955552 · Received February 11, 2013

    Report

    Report Number
    2530088-2013-10060
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 SYNTHES DEVICE HISTORY RECORD REVEALED THE LOT WAS MANUFACTURED AND PROCESSED PER SPECIFICATION REQUIREMENTS. THERE WERE NO COMPLAINT-RELATED ANOMALIES, MRRS, OPERATING ROOM NCRS ASSOCIATED WITH THIS LOT. THE PRODUCT EVALUATION REVEALED THAT DUE TO AN UNKNOWN CAUSE, THE TIP BROKE OFF ON THE LCP-DHHS COUPLING SCREW. THE SHAFT EXHIBITS SOME SLIGHT SCUFF MARKS AND SCRATCHES ALONG THE ENTIRE SURFACE AREA. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. 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.

    Description of Event or Problem · 1

    DURING A DYNAMIC HELICAL HIP SYSTEM PROCEDURE, TECHNICIAN WAS TIGHTENING SCREW FOR INSERTION AND THE SCREW BROKE INTO THE HELICAL BLADE. A BACK UP HELICAL BLADE WAS USED AND THE SURGEON PROCEEDED WITHOUT USING A CONNECTING SCREW. PROCEDURE WAS SUCCESSFUL AND PATIENT WAS NOT HARMED. THE SCREW AND THE BLADE ARE AVAILABLE FOR RETURN. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59642 LCP® DHHS(TM) COUPLING SCREW 324MM LXH SYNTHES BRANDYWINE 6280915

    Patients

    Seq Age Sex Outcome Treatment
    1