BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE AXSOS 4.0MM LOCKING SET

    MDR report key: 3940516 · Received July 17, 2014

    Report

    Report Number
    0008031020-2014-00324
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE REPORTED INCIDENT OF THE BREAKAGE OF THE DRILL SLEEVE COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE CURRENTLY AVAILABLE INFORMATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO A USER-RELATED ISSUE. THE BREAKAGE WAS PROBABLY CAUSED BY MISUSE OF THE DEVICE, EITHER BY WRONG POSITIONING OF THE DRILL SLEEVE OR BY THE USE OF EXCESSIVE FORCE. ADDITIONALLY, IT CANNOT BE EXCLUDED THAT THE DEVICE WAS PRE-DAMAGED FROM A PREVIOUS PROCEDURE SINCE IT IS INTENDED FOR MULTIPLE USE (EITHER DURING CLEANING, STERILIZATION OR SURGICAL PROCEDURE). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. DEVICE WAS NEVER RETURNED.

    Description of Event or Problem · 1

    ACCORDING TO OUR SURGICAL ASSISTANT, THE LOCKING TIP OF THE DRILL SLEEVE AXSOS 4.0MM LOCKING SET, WAS BROKEN WHEN THE SURGEON WAS TRYING TO FIX THE PLATE.

    Description of Event or Problem · 1

    ACCORDING TO OUR SURGICAL ASSISTANT, THE LOCKING TIP OF THE DRILL SLEEVE AXSOS 4.0MM LOCKING SET, WAS BROKEN WHEN THE SURGEON WAS TRYING TO FIX THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418964 DRILL SLEEVE AXSOS 4.0MM LOCKING SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH (MDR) 02212R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other