BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM

    MDR report key: 6517298 · Received April 24, 2017

    Report

    Report Number
    0009610622-2017-00123
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540399731
    PMA / PMN Number
    K032579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM IS THE ONLY REPORTED DEVICE AND CONSIDERED THE PRIMARY PRODUCT. A FURTHER ASSOCIATED PRODUCT (THE TITANIUM LOCKING SCREW - ALLEGEDLY FOUND IN THE PACKAGING OF THE PRIMARY PRODUCT) WAS RETURNED, BUT WAS NOT PART OF THE PRODUCT INQUIRY (PRODUCT GRID). NEVERTHELESS, SINCE THE ISSUE IS ABOUT A PACKAGE WHICH ALLEGEDLY CONTAINED A DIFFERENT PRODUCT THAN LABELLED, THE MANUFACTURING DOCUMENTS OF THE (ASSOCIATED) TITANIUM LOCKING SCREW HAVE ALSO BEEN REVIEWED, IN PARTICULAR THE PACKAGING / LABELING DOCUMENTS; NO DEVIATION WAS FOUND. LIKEWISE, THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM (STAINLESS STEEL) REVEALED NO CONSPICUITIES, IN PARTICULAR REGARDING THE PACKAGING / LABELING DOCUMENTS. THE TOTAL QUANTITY OF LABELS USED FOR BOTH LOCKING SCREWS WAS VERIFIED; NO DEVIATION WAS FOUND. BOTH PRODUCTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE A MIX-UP DURING THE PACKAGING PROCESS CAN BE EXCLUDED. THE LOCKING SCREWS WERE PACKED AT DIFFERENT LOCATIONS; THE TIME INTERVAL BETWEEN BOTH PACKAGING PROCESSES WAS THREE WEEKS. THE REPORTED EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE PRODUCT(S) RESP. BY A MISLABELING BY THE MANUFACTURER. BASED ON THE FACT, THAT BOTH ITEMS (LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM, CATALOGUE # 17965040S, LOT CODE K07C716 AND LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM, CATALOGUE # 18965040S, LOT CODE K0C971B) WERE DELIVERED TO THE COMPLAINING HOSPITAL, A MIX-UP IN THE HOSPITAL APPEARS MORE LIKELY THAN AN ERROR DURING THE PACKAGING PROCESS, WHICH IS PRECISELY DOCUMENTED WITHOUT INDICATION OF DEVIATION. CONSIDERING THE ABOVE OBSERVATIONS ANY REVIEW OF COMPLAINT HISTORY AND RISK ANALYSIS WAS DISPENSABLE IN THIS CASE AND ANY POTENTIAL CORRECTIVE / PREVENTIVE ACTIONS HAVE BEEN DEEMED UNNECESSARY. THE ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. 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

    IT WAS REPORTED THAT WHEN CUSTOMER OPENED A PACKAGE OF A STAINLESS STEEL SCREW IT WAS NOTICED THAT THE PACKAGE CONTAINED A DIFFERENT PRODUCT (TITANIUM SCREW K0C971B).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CUSTOMER OPENED A PACKAGE OF A STAINLESS STEEL SCREW IT WAS NOTICED THAT THE PACKAGE CONTAINED A DIFFERENT PRODUCT (TITANIUM SCREW K0C971B).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296863 LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 1796-5040S K07C716 04546540399731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other