BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO QC DRILL BIT 2.5/110/85 (GOLD)

    MDR report key: 9871745 · Received March 24, 2020

    Report

    Report Number
    3008951116-2020-00004
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 24, 2020
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    UDI-DI
    05055662931105
    PMA / PMN Number
    K102743
    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. NO ANOMALIES OR DEVIATIONS WERE NOTED IN THE MANUFACTURE OF THIS BATCH OF DRILLS WHICH MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DRILL BIT DURING OPERATION. THUS, THE MANUFACTURE OF THE BATCH IS THEREFORE NOT LIKELY TO HAVE BEEN A CAUSE FOR THE DRILL FRACTURE REPORTED. THE INVESTIGATION WAS LIMITED AS THERE WAS A LACK OF CLINICAL INFORMATION, AND THE COMPLAINT DEVICE WAS DISCARDED, THUS NOT ALLOWING FOR VISUAL INSPECTION OR TESTING FOR MATERIAL ANOMALIES AND INSIGHT INTO THE MODE OF FRACTURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF FAILURE, THE FAILURE RATE FOR THE PRODUCT REMAINS TO BE LOW AND THERE WERE NO ISSUES FOUND WITH THE MANUFACTURE OF THE BATCH OF DRILLS. THE OS200125 DRILL AND OTHER ORTHO SOLUTIONS DRILLS SHARING A SIMILAR DESIGN WERE FOUND TO BE WELL-PERFORMING WHEN COMPARED TO REPORTED RATES IN LITERATURE. BASED ON THE PRODUCT FAILURE RATE AND THE RESULTS FROM THE INVESTIGATIONS CONDUCTED, THERE ARE CURRENTLY NO CORRECTIVE ACTIONS TO BE TAKEN. THIS COMPLAINT WILL HOWEVER BE MONITORED THROUGH ORTHO SOLUTION'S POST MARKET SURVEILLANCE PROCEDURES FOR RE-OCCURRENCE AND ANY EVIDENCE OF NEGATIVE TREND.

    Description of Event or Problem · 1

    THE DRILL FRACTURED DURING SURGERY. A SECOND DRILL OF THE SAME PRODUCT CODE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MINOR DELAY CAUSED. MOST OF THE DRILL TIP (THE FLUTED SECTION) REMAINS INSIDE THE PATIENT. THE SURGEON DECIDED NOT TO ATTEMPT TO REMOVE THE BROKEN DRILL SECTION. NO ADDITIONAL PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336480 AO QC DRILL BIT 2.5/110/85 (GOLD) FLUTED SURGICAL DRILL BIT, SINGLE-USE, STERILE HTW ORTHO SOLUTIONS UK LTD OS200125 1A2869 05055662931105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other