BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/

    MDR report key: 9583195 · Received January 13, 2020

    Report

    Report Number
    1219602-2020-00082
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 20, 2019
    Report Date
    April 21, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010555694
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 3.5 INCISOR PLUS ELITE BLADE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. FUNCTIONAL INSPECTION CONFIRMED THE INNER BLADE DOES NOT ROTATE FREELY WITHIN THE OUTER BLADE, FRICTION WAS FELT IN THE UNLOADED CONDITION. VISUAL ASSESSMENT OF THE DEVICE SHOWED THE OUTER BLADE IS BENT. THERE ARE VISUAL SIGNS OF MATERIAL GALLING AND DEBRIDEMENT ON THE INNER AND OUTER BLADE SURFACES CONFIRMING THE REPORTED SHEDDING. THE CONDITION OF THE DEVICE INDICATES IT WAS SUBJECTED TO EXCESSIVE SIDE LOADING DURING USE. PER THE DEVICE INSTRUCTION FOR USE UNDER PRECAUTIONS ¿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¿. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. BASED SOLELY ON THE PRODUCT EVALUATION THE ROOT CAUSE OF THE REPORTED ISSUE IS LIKELY DUE TO A USER VS PROCEDURAL EVENT. THE INSTRUCTION FOR USE DOES CAUTION THAT ¿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¿. THE RETAINED METAL DEBRIS IS NEITHER BIO-INERT NOR APPROVED FOR IMPLANTATION AND IT IS UNKNOWN HOW MUCH REMAINS WITHIN THE SURGICAL SITE AND ALSO UNKNOWN IF CORROSION, MICRO-MOTION AND/OR MIGRATION OF THE RETAINED METAL DEBRIS WILL OCCUR. THE PATIENT IMPACT BEYOND THE REPORTED EVENTS CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H10. H3, H6: THE REPORTED 3.5 INCISOR ELITE BLADE, USED IN TREATMENT, HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT A VISUAL OR FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, THE INNER BLADE SHED MATERIAL 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 OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE OF THE REPORTED METAL FLAKES COULD NOT BE DETERMINED. IT IS UNCLEAR IF THE INSTRUCTIONS FOR USE WERE ADHERED TO HOWEVER, IT DOES CAUTION ¿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. THE RETAINED METAL DEBRIS IS NEITHER BIO-INERT NOR APPROVED FOR IMPLANTATION AND IT IS UNKNOWN HOW MUCH REMAINS WITHIN THE SURGICAL SITE AND ALSO UNKNOWN IF CORROSION, MICRO-MOTION AND/OR MIGRATION OF THE RETAINED METAL DEBRIS WILL OCCUR. THE PATIENT IMPACT BEYOND THE REPORTED EVENTS CANNOT BE DETERMINED. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE INCISOR PLUS ELITE BLADE WAS ACTIVATED, METAL FLAKES MADE FROM THE INNER BLADE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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
    45625 INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 72200095 50779887 03596010555694

    Patients

    Seq Age Sex Outcome Treatment
    1