BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM

    MDR report key: 7206030 · Received January 19, 2018

    Report

    Report Number
    0009610622-2018-00022
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 15, 2017
    Report Date
    May 10, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LPH
    PMA / PMN Number
    K153345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE MATCHED THE REPORT AND THE COMPLAINT FAILURE MODE WAS CONFIRMED. REFERRING TO PRODUCT INQUIRY THE GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM [PACKAGING] IS STATED TO BE THE PRIMARY PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. A REVIEW OF THE DHR REVEALED NO DISCREPANCIES. SEALING SEAMS AND ORIGINAL PACKAGING ARE STILL INTACT. THUS, THE POLLUTION MUST HAVE OCCURRED DURING THE PACKAGING PROCESS AT OUR SUB-SUPPLIER, 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 / INSUFFICIENT INSPECTION SPECIFICATION. THE FOUND HAIR HAS TO BE CLASSIFIED AS A NON-CONFORMANCE. NCR #1782107 WAS TRIGGERED FOR FURTHER ROOT CAUSE INVESTIGATION.

    Description of Event or Problem · 0

    IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER. NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

    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

    IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER. NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48339 GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES LPH STRYKER TRAUMA KIEL K0463A6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other