BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS PWR HIGH SPEED DRILL

    MDR report key: 11722134 · Received April 25, 2021

    Report

    Report Number
    1643264-2021-01533
    Event Type
    Injury
    Date Received
    April 25, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 9, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010466167
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED AND NO DEFICIENCIES WERE OBSERVED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. A FUNCTIONAL EVALUATION REVEALED A BLADE STALL ERROR MESSAGE AND EXCESSIVE HEAT PRODUCED FROM THE HANDPIECE. AN INVESTIGATION PERFORMED BY THE SUPPLIER REVEALED THE DEVICE FAILED THE TORQUE TEST AND HAS A GRINDING NOISE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH A MECHANICAL COMPONENT FAILURE. FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, INCLUDE CORROSION IN THE GEARBOX/MOTOR ASSEMBLY FROM CLEANING AND STERILIZATION METHODS AND THE CHEMICALS INVOLVED OVER A PERIOD OF TIME. A BLADE STALL CONDITION CAN RESULT IN INCREASED CURRENT DRAW FROM THE CONTROL UNIT WHICH WILL HEAT THE MOTOR AND HAND PIECE HOUSING. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IP JOINT FUSION THE DYONICS PWR HIGH SPEED DRILL DID NOT HAVE ANY POWER. THIS EVENT HAPPENED WITH A DYONICS PWR HIGH SPEED DRILL. HAND PIECE CONTROL ERROR MESSAGE WAS DISPLAYED IN THE SCREEN. INSTRUMENTS INSIDE PATIENT. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. PROCEDURE FINISHED WITH COMPETITOR DEVICE. NO PATIENT COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618202 DYONICS PWR HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 03596010466167

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention