BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALED DRILL 2.5MM, AO FITTING

    MDR report key: 10573207 · Received September 23, 2020

    Report

    Report Number
    0008031020-2020-02261
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 24, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    07613252719861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. THE EVENT DESCRIPTION STATES THAT: "DRILL WAS BENDING AT EXTREME ANGLE PRIOR TO BREAKAGE." BASED ON THIS STATEMENT, THE LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS LIKELY CAUSED BY THE BENDING OF THE DRILL DURING USE UNDER A POWER TOOL, WHICH APPLIES SIGNIFICANT FORCES ON THE DEVICE. 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.

    Description of Event or Problem · 0

    AS REPORTED: "2.5 MM X 450MM DRILL BIT (703966) BROKE OFF DURING DRILLING IN THE PUBIC RAMUS AND WAS NOT RETRIEVED. LOT # (KU90298). DRILL WAS BENDING AT EXTREME ANGLE PRIOR TO BREAKAGE. THE DRILL BIT WAS NOT RETRIEVED BECAUSE IT WOULD HAVE DONE MORE HARM TO THE PATIENT ATTEMPTING TO RETRIEVE IT. IT WAS FULLY CONTAINED IN THE BONE. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT AND CONCLUDED WITH A POSITIVE OUTCOME FOR BOTH SURGEON AND PATIENT."

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED: "2.5 MM X 450MM DRILL BIT (703966) BROKE OFF DURING DRILLING IN THE PUBIC RAMUS AND WAS NOT RETRIEVED. LOT # (KU90298). DRILL WAS BENDING AT EXTREME ANGLE PRIOR TO BREAKAGE. THE DRILL BIT WAS NOT RETRIEVED BECAUSE IT WOULD HAVE DONE MORE HARM TO THE PATIENT ATTEMPTING TO RETRIEVE IT. IT WAS FULLY CONTAINED IN THE BONE. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT AND CONCLUDED WITH A POSITIVE OUTCOME FOR BOTH SURGEON AND PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039680 SCALED DRILL 2.5MM, AO FITTING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 703966 KU90298 07613252719861

    Patients

    Seq Age Sex Outcome Treatment
    1