BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRADER 5.5 EP-1 DSPL BLADE

    MDR report key: 10423588 · Received August 18, 2020

    Report

    Report Number
    1219602-2020-01268
    Event Type
    Injury
    Date Received
    August 18, 2020
    Report Date
    March 20, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    UDI-DI
    03596010251534
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: ONE 7205325 DISPOSABLE 5.5MM EP-1 ABRADER BLADE USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, EVALUATION WAS LIMITED. IF FURTHER INFORMATION, BECOMES AVAILABLE, THE COMPLAINT MAY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. 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) BLADE HAND PIECE NOT FULLY LOADED AND OR LOCKED INTO MDU HAND SET. 5) CHANGE OF APPROACH DURING USE. PER IFU1060595: ¿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. MAKE SURE THE HAND PIECE IS OFF WHILE CHANGING BLADE TIP POSITION. 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).¿ COMPLAINT HISTORY REVIEW INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. INSTRUCTIONS FOR USE (IFU) CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED FAILURE. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H3,H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES CONFIRMED THE PART AND BATCH NUMBERS OF THE DEVICE. IT ALSO REVEALED THAT THE SECOND HEAT SHRINK TUBE WAS ABSENT. A VISUAL INSPECTION REVEALED THAT THE SUSPECTED DEVICE WAS FREE OF DEBRIS, SO THERE WERE NOT VISIBLE METAL SHAVINGS ON THE BLADE INNER OR OUTER BLADES. AT THE DISTAL END OF THE INNER BLADE, THE SECOND HEAT SHRINK WAS ABSENT. THE WELDS WERE EXPOSED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF THE PART DRAWING FOUND THAT TWO HEAT SHRINKS WERE SPECIFIED ON THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A REVIEW OF THE INSTRUCTIONS FOR USE FOUND THE FOLLOWING WARNINGS RELATED TO THE REPORTED FAILURE MODE: 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. MAKE SURE THE HAND PIECE IS OFF WHILE CHANGING BLADE TIP POSITION. 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). A CLINICAL/MEDICAL INVESTIGATION CONCLUDED THE PATIENT IMPACT BEYOND POSSIBLE CORROSION, LOCAL IRRITATION/DISCOMFORT, AND/OR MIGRATION OF THE POSSIBLE RETAINED METAL DEBRIS CANNOT BE DETERMINED. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS COMPLETED. SINCE THERE WERE NO OTHER COMPLICATIONS REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS COMPLETED. NO 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
    883407 ABRADER 5.5 EP-1 DSPL BLADE SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 7205325 50832010 03596010251534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other