BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 2.0MM X 123MM CALIBRATED

    MDR report key: 9883035 · Received March 26, 2020

    Report

    Report Number
    3008951116-2020-00005
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    UDI-DI
    05055662930726
    PMA / PMN Number
    K111678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE PRODUCT WAS SUPPLIED IN CONFORMANCE WITH ORTHO SOLUTIONS SPECIFICATIONS AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED IN THE MANUFACTURING OF THE BATCH WHICH MAY HAVE CONTRIBUTED TO THE FRACTURE. NO TESTS ON THE COMPLAINT DEVICE COULD BE CONDUCTED AS THE DRILL WAS NOT AVAILABLE TO BE RETURNED. TREND ANALYSIS OF THE OS200020LC DRILL HAS SHOWN THAT THE DEVICE IS WELL-PERFORMING AND NO NEGATIVE TREND HAS BEEN OBSERVED. BASED ON THE CLINICAL INFORMATION PROVIDED REGARDING THE SURGICAL TECHNIQUE, A NUMBER OF POSSIBILITIES WERE IDENTIFIED WHICH MAY HAVE CAUSED THE FAILURE OF THE DRILL BIT. HOWEVER, DESPITE THE FINDINGS FROM THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS THE 4TH COMPLAINT FOR THIS PRODUCT AND BASED ON THE TREND ANALYSIS, THE FAILURE RATE IS DEEMED TO BE LOW AT (B)(4). ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF FAILURE, THERE HAS BEEN NO INDICATION OF A NEW OR EMERGING RISK WITH THIS DEVICE, AND NO NEGATIVE TREND HAS BEEN IDENTIFIED. COMPLAINT CONDITION HAS BEEN IDENTIFIED AS PART OF THE RISK ASSESSMENT PROCEDURE, AND NO EMERGING OR NEW RISKS HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS DRILLING WITH THE DRILL BIT IN RIGHT 1ST MTJ FUSION PROCEDURE, IT BROKE INSIDE THE PATIENT AND THE FLUTED PORTION OF THE DRILL IS EMBEDDED IN THE PATIENT'S BONE. THE SURGEON DECIDED THAT LEAVING IT IN WOULD CAUSE LESS HARM. NO ADDITIONAL PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347517 DRILL BIT 2.0MM X 123MM CALIBRATED FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE HTW ORTHO SOLUTIONS UK LTD OS200020LC 1088789 05055662930726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other