BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM

    MDR report key: 4745974 · Received May 4, 2015

    Report

    Report Number
    0009610622-2015-00222
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 16, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PRODUCT INQUIRY STATES THE GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. A REVIEW OF THE DHR REVEALED NO DISCREPANCIES. THE REPORTED EVENT WAS CONFIRMED. ALL SEALS AND ORIGINAL PACKAGING ARE STILL INTACT. THUS, THE POLLUTION MUST HAVE OCCURRED DURING THE PACKAGING PROCESS AT STERIPACK, WHICH WAS NOT DETECTED DURING INSPECTION. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO AN INADEQUATE PACKAGING PROCESS. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. THE FOUND BLACK PARTICLE HAS TO BE CLASSIFIED AS A NON-CONFORMANCE. NCR # 900753 WAS INITIATED FOR FURTHER ROOT CAUSE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL IN INNER BLISTER PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL IN INNER BLISTER PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291076 GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K0B2759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other