BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 2.0MM DRILL

    MDR report key: 12370011 · Received August 26, 2021

    Report

    Report Number
    3008951116-2021-00006
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RESPONSE WAS OBTAINED FROM THE HOSPITAL, SO THE COMPLAINT PRODUCT CODE AND BATCH IS UNKNOWN. ERP ANALYSIS OF SALES TO THE HOSPITAL WITHIN THE REPORTED TIME PERIOD SUGGESTED THE PROBABLE DRILL WAS (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE IDENTIFIED DRILL BATCHES SOLD TO THE ROYAL BOLTON HOSPITAL SHOWED THAT THE PRODUCTS WERE SUPPLIED IN CONFORMANCE TO SPEFICIATIONS AND REVEALED NO DEVIATIONS OR NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DRILL FAILURE. TREND ANALYSIS OF THE POSSIBLE COMPLAINT DRILL ((B)(4)) IDENTIFIED A LOW FAILURE RATE OF 0.0088%, AND NO NEGATIVE TRENDS HAVE BEEN IDENTIFIED. AS NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL, THE INVESTIGATION WAS LIMITED, AND THE ROOT CAUSE UNABLE TO BE ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAN AN ORTHO SOLUTIONS 2.0MM DRILL BIT BROKE WHILST IN USE IN PATIENTS BONE. A SECOND CONSULTANT ADVISED AND THE DECISION WAS MADE THAT IT WAS SAFER FOR THE PATIENT TO LEAVE BROKEN DRILL PIECE IN THE BONE AS IT WOULD CAUSE FURTHER DAMAGE TO REMOVE IT. NO DEVICE INFORMATION WAS PROVIDED AND THE COMPLAINT DEVICE WAS NOT RETURNED. THE CONDITIONS OF USE AND THE SURGICAL PROCEDURE IS UNKNOWN AT THIS TIME. NO FURTHER COMPLICATIONS OR INJURY WERE REPORTED. THE REPORTER WAS CONTACTED ON MULTIPLE OCCASIONS AND NO RESPONSE WAS GIVEN. SHOULD THERE BE ANY CHANGES TO THE CONCLUSION OF THIS COMPLAINT'S INVESTIGATION AS A RESULT OF UPDATE OF INFORMATION, THIS REPORT SHALL BE APPROPRIATELY UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267727 UNKNOWN 2.0MM DRILL FLUTED SURGICAL DRILL BIT, SINGLE-USE HTW ORTHO SOLUTIONS UK LTD UNKNOWN 2.0MM DRILL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other