BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORESORBABLE PIN SONICPIN Ø2.2X26 MM

    MDR report key: 2990060 · Received March 5, 2013

    Report

    Report Number
    0009610622-2013-00092
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HTY
    PMA / PMN Number
    K091955-LTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: DEVIATIONS IN MANUFACTURING WERE NOT FOUND. THE ITEM REMAINED IMPLANTED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT. A REVIEW OF THE RISK FILE REVEALED THAT THE OVERALL RISK CATEGORY WAS ADDRESSED ADEQUATELY AS NO DISCREPANCIES WERE IDENTIFIED. INVESTIGATION REVEALED NO NON-CONFORMITY, THEREFORE NO CAPA WAS INITIATED. ACCORDING TO LATER CONVERSATION WITH THE SURGEON THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE. THE EVENT WAS RATHER CAUSED BY DEVIATION FROM SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING A SONIC PIN, DID EVERYTHING ACCORDING TO DIRECTIONS. DRILL DID NOT CROSS THE OSTEOTOMY SITE TO PROVIDE ADEQUATE FIXATION. LEFT IN THE PATIENT, DEVICE NEEDED TO BE LONGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING A SONIC PIN, DID EVERYTHING ACCORDING TO DIRECTIONS. DRILL DID NOT CROSS THE OSTEOTOMY SITE TO PROVIDE ADEQUATE FIXATION. LEFT IN THE PATIENT, DEVICE NEEDED TO BE LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93129 BIORESORBABLE PIN SONICPIN Ø2.2X26 MM IMPLANT HTY STRYKER OSTEOSYNTHESIS-KIEL K279260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other