BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM X 28MM BIOABSORBABLE ACL SCREW

    MDR report key: 3873109 · Received June 13, 2014

    Report

    Report Number
    0002936485-2014-00410
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HWC
    PMA / PMN Number
    K993166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED. BASED ON THE AVAILABLE INFORMATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED BUT SOME POTENTIAL REASONS FOR FAILURE ARE LISTED BELOW: EXCESSIVE INSERTION FORCE, SCREW INSERTED AT AN ANGLE, SCREW INSERTED OVER A BENT/DAMAGED GUIDE WIRE, SCREWDRIVER TIP WAS BENT/DAMAGED, EXCEPTIONALLY HARD PATIENT BONE, INCORRECTLY SIZED INSERTION TUNNEL, SCREWDRIVER NOT FULLY ENGAGED IN THE SCREW. IT IS UNLIKELY THAT PROCESSING/MANUFACTURING RELATED ISSUES WERE THE CAUSE OF THE FAILURE AS THIS IS THE ONLY REPORTED FAILURE FOR THIS LOT. IF MORE INFORMATION OR THE DEVICE BECOME AVAILABLE THE THEN THE INVESTIGATION WILL BE REOPENED. IN SUM, THE PRODUCT WAS NOT RECEIVED AND THE FAILURE MODE WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE OFF INTO THE PATIENT DURING SURGERY. A PART OF THE SCREW WAS REMOVED WITH A SCREWDRIVER, BUT A PART OF IT REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE OFF INTO THE PATIENT DURING SURGERY. A PART OF THE SCREW WAS REMOVED WITH A SCREWDRIVER, BUT A PART OF IT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350004 8MM X 28MM BIOABSORBABLE ACL SCREW SCREW, FIXATION, BONE HWC STRYKER ENDOSCOPY-SAN JOSE A9955

    Patients

    Seq Age Sex Outcome Treatment
    1