BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    MDR report key: 5868120 · Received August 11, 2016

    Report

    Report Number
    0009610622-2016-00397
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 14, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATES THE GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 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 STRYKER (B)(4), 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. THE FOUND BLACK FIBER ACCUMULATIONS HAVE TO BE CLASSIFIED AS A NON-CONFORMANCE. NCR WAS INITIATED FOR FURTHER ROOT CAUSE INVESTIGATION. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.

    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 IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 80 UNITS, LOT#K06198E RECEIVED ON OUR PO#(B)(4).

    Description of Event or Problem · 1

    IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 80 UNITS, LOT#K06198E RECEIVED ON OUR PO#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522481 GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K06198E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other