BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10965

    MDR report key: 3003417 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10965
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    April 14, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PT WITH A MIGRATED TFN HELICAL BLADE IN ONE PROXIMAL FEMUR AND A MIGRATED DHS LAG SCREW IN THE OTHER PROXIMAL FEMUR. THE NAIL, HELICAL BLADE AND LOCKING SCREW ARE SYNTHES PRODUCTS. THE DHS LAG SCREW IS NOT SYNTHES' PRODUCT, INSTEAD IT IS A SLIDING HIP PLATE SCREW - AMBI FROM SMITH AND NEPHEW. PT COMPLAINED OF HIP PAIN TO THE SURGEON. BASED ON THE COMPLAINT ABOUT PAIN, SURGEON ASSUMED MEDIAL MIGRATION. UPON REVIEW OF X-RAYS IT WAS DETERMINED THERE WAS NO MIGRATION. THE CURRENT SURGEON IS NOT THE INITIAL IMPLANTING SURGEON. NO ADDITIONAL INFO AVAILABLE REGARDING HOSP OR IMPLANTING SURGEON. THIS COMPLAINT IS ON THE HELICAL BLADE AND THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86879 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 DHS LAG SCREW| SLIDING HIP PLATE SCREW