BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" PEG DRILL

    MDR report key: 3011692 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01032
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE SURGERY THE DRILL BIT APPARATUS BROKE. THE BROKEN PIECE WAS REMOVED FROM THE KNEE. THE TWO PIECES WERE MATCHES AND REMOVED FROM THE STERILE FIELD. NO PIECES WERE MISSING. X-RAY OF RIGHT KNEE WAS TAKEN AND THE PHYSICIAN READ THE X-RAY AS NEGATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE SURGERY THE DRILL BIT APPARATUS BROKE. THE BROKEN PIECE WAS REMOVED FROM THE KNEE. THE TWO PIECES WERE MATCHES AND REMOVED FROM THE STERILE FIELD. NO PIECES WERE MISSING. X-RAY OF RIGHT KNEE WAS TAKEN AND THE PHYSICIAN READ THE X-RAY AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114912 1/8" PEG DRILL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SCZB04

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other