BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINLOOP FLEX DISPOSABLE DRILL

    MDR report key: 3133184 · Received May 29, 2013

    Report

    Report Number
    0002936485-2013-00227
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. NONETHELESS, THE REPORTED CONDITION IS A KNOWN FAILURE MODE, WHICH PROBABLE ROOT CAUSE(S) CAN BE ASSOCIATED, BUT NOT LIMITED TO: INADEQUATE SYSTEM DESIGN (STRENGTH) AND/OR INSERTION TECHNIQUE (USER ERROR). IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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 DURING THE PROCEDURE, THE DEVICE BROKE INSIDE THE BONE WHILE DRILLING A HOLE FOR AN IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE BROKE INSIDE THE BONE WHILE DRILLING A HOLE FOR AN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235529 TWINLOOP FLEX DISPOSABLE DRILL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ENDOSCOPY-SAN JOSE 12003AG2

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR