BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR Ø1.5 SELF-TAP L4 TAN 1U I/CLIP

    MDR report key: 3011199 · Received March 19, 2013

    Report

    Report Number
    1719045-2013-00609
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION SHOWS THAT THE MARKINGS ON THE PLASTIC CONTAINERS ARE INDEED WRONG. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE FOR THIS PROBLEM BUT WE SUPPOSE THAT ONE STEP DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT PROPERLY. THIS IS CLEARLY A MANUFACTURING FAULT. WE CAN ONLY PRESUME DESPITE THE SMALL PROBABILITY OF SUCH OCCURRENCE THAT THERE WAS A LAPSE IN OUR QUALITY CONTROL AND THESE PARTICULAR ARTICLES WERE INADVERTENTLY PACKED WITHOUT HAVING GONE THROUGH PROPER CONTROL. THE SCREWS HAVE BEEN RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT WAS RECEIVED AND THE INVESTIGATION IS ON GOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT WAS RETURNED IN NON-SYNTHES PACKAGING WITH FIVE SCREWS IN ONE POUCH AND 5 CLIPS IN A SECOND POUCH. MANUFACTURING EVALUATION COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT SUPPLIED WITH COMPLAINT. CAPA (B)(4) WAS OPENED FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS 1 OF 11 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE SIZE OF THE SCREW IS INCORRECT. THE INCORRECT SIZES IN THE CLIPS WERE 6MM AND NOT 4MM. IT WAS REPORTED THE SCREWS WERE NOT RETAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113353 SCR Ø1.5 SELF-TAP L4 TAN 1U I/CLIP JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1