BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3092533 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00235
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. THE CUSTOMER DEFINED THE GUIDE WIRE TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. BECAUSE THE PRODUCT IS NOT AVAILABLE AND NO FURTHER INFORMATION LIKE X-RAYS WERE PROVIDED AN INVESTIGATION OF THE CASE WAS NOT POSSIBLE. THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. MOST LIKELY THE CUSTOMER DAMAGED THE GUIDE WIRE DURING REAMING PROCESS. A MORE PRECISE EVALUATION WAS NOT POSSIBLE DUE TO MISSING PRODUCT AND INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) MALE PATIENT WAS UNDERGOING REPAIR OF THE FRACTURED LEFT FEMUR AND TIBIA. WHILE PLACING THE BALL TIP GUIDEWIRE DOWN THE LEFT TIBIAL CANAL, A 1-2 IN PIECE OF THE WIRE BROKE OFF IN THE TIBIAL CANAL AND WAS RETAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A (B)(6) MALE PATIENT WAS UNDERGOING REPAIR OF THE FRACTURED LEFT FEMUR AND TIBIA. WHILE PLACING THE BALL TIP GUIDEWIRE DOWN THE LEFT TIBIAL CANAL, A 1-2 IN PIECE OF THE WIRE BROKE OFF IN THE TIBIAL CANAL AND WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194700 GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K630464

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other