BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    MDR report key: 4763311 · Received May 11, 2015

    Report

    Report Number
    0009610622-2015-00236
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 24, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PRODUCT INQUIRY STATES BOTH LOCKING SCREWS, FULLY THREADED T2 TIBIA Ø5X40 MM TO BE THE SUBJECT PRODUCTS. A REVIEW OF THE DHR REVEALED NO DISCREPANCIES AND THE ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE IMAGE PROVIDED SHOWED DISCREPANCIES BETWEEN SIDE AND BOTTOM LABEL REGARDING THE CAT. #. THE LABEL AT THE BOTTOM SIDE PRESENTS CAT. # 18965040S (EXPIRY DATE 2019-11) AND THE SIDE LABELS PRESENT CAT. # 18965045S (EXPIRY DATE 2019-11) [1]. OPTICAL EVALUATION, BASED ON THE IMAGE PROVIDED, REVEALED THAT THE OVERWRAP-FOIL IS NO STRYKER (B)(4) STANDARD AS NO PERFORATION COULD BE VERIFIED AND FURTHER, SEALING SEAMS ARE VISIBLE AT ONE LONGITUDINAL SIDE, WHICH IS NOT ORIGINALLY PROVIDED AT THIS AREA. FURTHERMORE, SMALL STICKERS WITH STRYKER IMPRINT ARE VISIBLE UNDER THE FOIL AT BOTH LONGITUDINAL SIDES, WHICH IS NOT ORIGINALLY PROVIDED BY THE MANUFACTURER AS WELL. THUS, IT IS OBVIOUS THAT THE PACKAGING WAS RE-WRAPPED, WHICH IS BEYOND THE MANUFACTURER¿S CONTROL. MOST LIKELY THE MIX-UP OF THE UPPER AND LOWER PARTS OCCURRED DURING THE RE-WRAPPING OF THE DEVICES. ADDITIONALLY, THE WHOLE PACKAGING PROCESS FOR THE SCREWS Ø5X40 MM CAT. # 18965040S (LOT CODE K073B1A), IN PARTICULAR THE LABELLING, WAS PERFORMED AT OUR SUPPLIER DOT. FOR THE SCREW Ø5X45 MM CAT. # 18965045S (LOT CODE K05241D) THE PACKAGING WAS PERFORMED AT STRYKER (B)(4). THUS, A MANUFACTURING ERROR RESP. A MIX-UP AT THE MANUFACTURING SITE COULD BE EXCLUDED. THE ROOT CAUSE WAS ALREADY GIVEN IN THE CANCELLED PRODUCT RETURN CHILD. ACCORDING TO FURTHER INFORMATION RECEIVED ¿WHEN THE PI WAS OPENED, STRYKER (B)(4) ALSO STARTED AN INTERNAL INVESTIGATION AND WE CONCLUDED THERE WAS A MISUNDERSTOOD IN THE LOGISTIC OPERATOR. CORRECTIVE ACTIONS WILL BE TAKEN BY STRYKER (B)(4). NO PRODUCTS WILL BE RETURNED FOR INVESTIGATION¿. THIS INQUIRY DOES NOT PRESENT A COMPLAINT REGARDING PRODUCT QUALITY AND IS NEITHER DEVICE NOR MANUFACTURING RELATED. IT RATHER REFLECTS A DEFICIENCY IN THE FURTHER TREATMENT RESPECTIVELY IN THE FLOW AT DISTRIBUTION SITE. THE EVENT WAS NOT CAUSED BY PRODUCT DEFICIENCY. DEVICE WAS NEVER RECEIVED.

    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 THE EXTERNAL LABELS DON'T MATCH, LATERAL VERSUS FRONT AND BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL LABELS DON'T MATCH, LATERAL VERSUS FRONT AND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307958 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL (MDR) K05241D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other