BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADLESS PIN EXTRACTOR

    MDR report key: 4243333 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04228
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 4 OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT WAS CONFIRMED. THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    LOANER STAFF OF STRYKER (B)(4) NOTICED THE DEFORMATION OF THE DEVICE HANDLE AFTER IT WAS RETURNED FROM THE HOSPITAL. THE DEVICE WAS USED IN THE MEDICAL PROCEDURE, BUT WHEN THE DEFORMATION OF THE DEVICE WAS OCCURRED.

    Description of Event or Problem · 1

    LOANER STAFF OF STRYKER (B)(4) NOTICED THE DEFORMATION OF THE DEVICE HANDLE AFTER IT WAS RETUREND FROM THE HOSPITAL. THE DEVICE WAS USED IN THE MEDICAL POCEDURE, BUT WHEN THE DEFORMATION OF THE DEVICE WAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725072 HEADLESS PIN EXTRACTOR INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH MC4W01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other