BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABRADER,4.0,EP-1,DSPL BLADE

    MDR report key: 9861304 · Received March 20, 2020

    Report

    Report Number
    1219602-2020-00538
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    February 25, 2020
    Report Date
    April 23, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010251527
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: ONE 7205324 DISPOSABLE 4.0MM EP-1 ABRADER BLADE REPORTED ON. THE PRODUCT WAS USED FOR TREATMENT BUT WAS NOT RETURNED FOR EVALUATION. THIS PRODUCT IS SOLD AS A BOX OF 6; NOT INTENDED TO BE SOLD INDIVIDUALLY. DUE TO UNAVAILABILITY, EVALUATION WAS LIMITED. IF FURTHER INFORMATION BECOMES AVAILABLE, THE COMPLAINT MAY BE REVISITED. INSTRUCTION FOR USE DOCUMENTATION CONTAINS PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: PROCEDURE LOCATION AND TISSUE CONDITION, DEVICE ABILITY AND SURGICAL ABILITY. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY THAT ARE UNRELATED TO MANUFACTURE INCLUDE: 1) INCOMPATIBLE FORCE OR TORQUE OR LEVERAGE APPLIED. 2) INSUFFICIENT IRRIGATION OR ENGAGING THE DEVICE WITHOUT SUCTION. 3) SEIZING OF BLADES DUE TO INADEQUATE BIO MATTER EXCISION. 4) CHANGE OF APPROACH DURING USE. PER INSTRUCTION FOR USE: ¿IRREVERSIBLE DAMAGE MAY OCCUR TO BLADES OR BURRS IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY). PERIODIC IRRIGATION OF THE BLADE IS RECOMMENDED TO PROVIDE ADEQUATE COOLING OF THE BLADE AND TO PREVENT ACCUMULATION OF EXCISED MATERIALS IN THE SURGICAL SITE. ENSURE THAT SUCTION OF 128 MMHG MINIMUM IS FLOWING WHILE THE INSTRUMENT IS RUNNING. IRREVERSIBLE DAMAGE TO BLADES OR BURRS WILL RESULT IF THEY ARE RUN WITHOUT THE FLOW OF IRRIGATION (DRY). 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.¿ COMPLAINT HISTORY REVIEW INDICATED A SIMILAR ALLEGATION FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE BLADE BROKE INSIDE THE PATIENT HOWEVER IT IS UNKNOWN IF PIECES WERE RETRIEVED AND HOW. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SINCE NO BACK UP WAS AVAILABLE. NO PATIENT INJURIES OR DELAY 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
    324676 ABRADER,4.0,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 7205324 50779782 03596010251527

    Patients

    Seq Age Sex Outcome Treatment
    1