BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR,SLAP,4.5MM DSPL,DYO PWR /6

    MDR report key: 8207487 · Received January 1, 2019

    Report

    Report Number
    1219602-2019-00001
    Event Type
    Malfunction
    Date Received
    January 1, 2019
    Date of Event
    December 7, 2018
    Report Date
    June 4, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010463418
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 4.5MM SLAP BURR WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE HOODED PORTION OF THE OUTER SHEATH HAS BROKEN OFF AT THE WELDMENT AND WAS NOT RETURNED. FUNCTIONAL INSPECTION WAS PERFORMED AND THE INNER BURR DID NOT ROTATE FREELY WITHIN THE OUTER BLADE, FRICTION WAS FELT IN THE UNLOADED CONDITION. THE CONDITION OF THE DEVICE INDICATES IT WAS SUBJECTED TO EXCESSIVE SIDE LOADING DURING USE. PER THE DEVICES INSTRUCTIONS FOR USE ¿EXCESSIVE ¿SIDE-LOADING¿ ON THE BLADE DURING USE DOES NOT IMPROVE CUTTING PERFORMANCE AND IN EXTREME CASES MAY RESULT IN WEAR AND DEGRADATION OF THE INNER ASSEMBLY¿.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A PORTION OF METAL TIP OF BURR BROKE OFF INTO PATIENT SHOULDER. ALL PIECES RETRIEVED. NO APPARENT HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WAS BACK-UP DEVICE AVAILABLE AND IF THERE WAS A DELAY IN THE CASE. ATTEMPTS WERE MADE TO RETRIEVE FURTHER INFORMATION BUT NO RESPONSE WAS RECEIVED FROM THE COMPLAINANT.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. IT IS DIFFICULT TO PERFORM AN ACCURATE EVALUATION OF A FAILURE WITHOUT HAVING THE FAILED PRODUCT. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION. HOWEVER, IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED. EVENT DESCRIPTION CORRECTION. NOT A HEALTH PROFESSIONAL LEAVE IT WITHOUT ANY VALUE COMPANY REPRESENTATIVE AND NO HEALTH PROFESSIONAL USAGE OF DEVICE, INITIAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTION OF METAL TIP OF BURR BROKE OFF INTO PATIENT SHOULDER. ALL PIECES RETRIEVED. NO APPARENT HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A PORTION OF METAL TIP OF BURR BROKE OFF INTO PATIENT SHOULDER. ALL PIECES RETRIEVED. NO APPARENT HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WAS BACK-UP DEVICE AVAILABLE AND IF THERE WAS A DELAY IN THE CASE. ATTEMPTS WERE MADE TO RETRIEVE FURTHER INFORMATION BUT NO RESPONSE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50970672 03596010463418

    Patients

    Seq Age Sex Outcome Treatment
    1