BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOXED INCISOR PLUS BL,(BX6)

    MDR report key: 9373957 · Received November 26, 2019

    Report

    Report Number
    1219602-2019-01483
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    October 21, 2019
    Report Date
    February 11, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010251688
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TEN UNUSED BOXED INCISOR BLADES, INTENDED FOR USE IN TREATMENT, WERE RETURNED FOR EVALUATION. THE USED DEVICES WERE NOT RETURNED WHICH PROHIBITS CONFIRMATION OF THE CUSTOMER COMPLAINT. THE RETURNED UNUSED DEVICES WERE TESTED PER TSPEC BLADE/BURR SHEDDING TEST 1210265 AND WERE FOUND TO MEET SPECIFICATION. FROM THE INFORMATION PROVIDED, THE BLADES SHED DURING USE. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: EXCESSIVE SIDE LOADING DURING USE. THE INSTRUCTION FOR USE WAS REVIEWED AND WAS FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. PER THE PROVIDED COMMUNICATIONS, THE RETAINED METAL SHAVING RETAINED IN THE PATIENT¿S KNEE WERE WASHED OUT. ADDITIONALLY, A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. SINCE NO FURTHER HARM IS BEING ALLEGED TO THIS PATIENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT DATA BASE WAS PERFORMED, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND MENISECTOMY, WHEN THE SURGEON WAS USING THE 4.5MM BLADE, METAL SHAVINGS WERE OBSERVED IN THE KNEE; THESE WERE REMOVED BY WASHING THEM OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. 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
    1168759 BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 7205345 50779865 03596010251688

    Patients

    Seq Age Sex Outcome Treatment
    1