BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL SCREW DRILL BIT

    MDR report key: 3953352 · Received July 23, 2014

    Report

    Report Number
    0002249697-2014-02848
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING METAL DEBRIS INVOLVING A PERIPHERAL SCREW DRILL BIT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR INSPECTION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE AS THE DEVICE WAS NOT RETURNED FOR INSPECTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE DEVICE WAS NOT RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT A LITTLE BIT OF TRACE AMOUNT OF METAL DEBRIS CAME OFF FROM DRILL. SO SURGEON USED ANOTHER DRILL AND COMPLETE THE SURGERY SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT A LITTLE BIT OF TRACE AMOUNT OF METAL DEBRIS CAME OFF FROM DRILL. SO SURGEON USED ANOTHER DRILL AND COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431330 PERIPHERAL SCREW DRILL BIT INSTRUMENT KWS STRYKER ORTHOPAEDICS-MAHWAH SC10339L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other