BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRABTREE DISSECT JIMMY LG TIP BLADE 2MM

    MDR report key: 11761517 · Received May 3, 2021

    Report

    Report Number
    1423507-2021-00029
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 4, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    JYL
    UDI-DI
    10885403011580
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) SUPPLEMENTAL EMDR. A AU15190 CRABTREE DISSECT JIMMY LG TIP BLADE 2MM DEVICE WAS RETURNED FOR MANUFACTURING EVALUATION. THE SAMPLE WAS RETURNED FOR EVALUATION WITH LOT CODE J20 AND THE NORMAL AUTHENTIC V. MUELLER ETCHINGS IN THE NORMALLY ETCHED LOCATION ON THE HANDLE END. THE LOT CODE INDICATED A MANUFACTURE DATE OF OCTOBER 2020. UPON INITIAL INSPECTIONS THE SAMPLE WAS DISPLAYED IN NORMAL CONFORMING STATE, NO BROKEN PARTS, NO DAMAGES, AND NO HEAVY WEAR AND TEAR WAS OBSERVED. OVERALL, THE SAMPLE SURFACE'S DISPLAYED LIGHT WEAR AT THE WORKING ENDS, SLIGHT DISCOLORATION, AND SOME SCUFFING/SCRATCHING. BASED OFF THE VISUAL INSPECTION THE REPORTED FAILURE MODE WAS CONFIRMED AT THE WORKING END, THE VERY TIP OF THE SAMPLE HAD BROKEN OFF AND WAS NOT RETURNED OR NOTED ANYWHERE IN SAMPLE PACKAGING. UPON MAGNIFIED INSPECTIONS, THE BREAK AREA WAS NOTED TO BE DISCOLORED AND BROKEN APPROXIMATELY AT THE RIGHT-ANGLE BEND OF THE TIP. THE BROKEN TIP WAS NOT AVAILABLE HENCE IT WAS ESTIMATED THAT APPROXIMATELY 0.080 INCH OF THE TIP HAD BROKEN OFF AND WENT MISSING. THE BREAK WAS CHARACTERIZED AS A POSSIBLE DUCTILE TYPE BREAK UPON POSSIBLE IMPACT. FOR FURTHER INVESTIGATIONS THE SAMPLE WAS MEASURED PER PRODUCT SPECIFICATIONS AT 4 DIFFERENT POINTS. DIMENSIONS 1 AND 4 WERE NOTED TO BE WITHIN CONFORMANCE BUT, DIMENSIONS 2 AND 3 COULD NOT BE MEASURED DUE TO THE MISSING BROKEN TIP. DIMENSIONS 1 AND 4 WERE MEASURED ON THE THICKER SIDE OF THE PRODUCT SPECIFICATIONS. THE SAMPLE WAS ALSO TESTED FOR HARDNESS AND FOUND TO BE WITHIN CONFORMANCE. THE HARDNESS WAS MEASURED AT 50 ¿ 51 HRC, WHICH WAS WITHIN CONFORMANCE FOR THIS DEVICE. ADDITIONALLY, THE SHAFT WAS NOTED TO BE MALLEABLE AS NORMALLY MANUFACTURED. IT SHOULD BE NOTED THAT THIS AND SIMILAR PRODUCTS ARE MANUFACTURED, MARKETED, AND SOLD AS MALLEABLE AT THE SHAFT. NO BENDING OF THE SHAFT WAS OBSERVED AND NO FURTHER DAMAGES, CRACKS, OR SIGNS OF BREAKING OR WEAKENING WERE FOUND. THE SAMPLE WAS DETERMINED TO BE NORMALLY MANUFACTURED AND CONFORMING BEFORE THE FAILURE MODE OCCURRED. THE OBSERVATIONS MADE ON THE BROKEN AREA INDICATE THAT POSSIBLE EXCESSIVE FORCES WERE APPLIED AT THE TIP CAUSING IT TO BREAK BUT THE SPECIFIC SCENARIO OF HOW THE BREAK OCCURRED ARE NOT KNOWN. H3 OTHER TEXT: N/A.

    Description of Event or Problem · 0

    TIP OF THE DEVICE BROKE OFF DURING USE IN A TYMPANOPLASTY AND MASTOIDECTOMY. IT FELL INTO THE PATIENT'S EAR AND WAS CLEARED OUT USING SUCTION. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. IF A SAMPLE DOES BECOME AVAILABLE FOR INVESTIGATION A SUPPLEMENTAL EMDR WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    TIP OF THE DEVICE BROKE OFF DURING USE IN A TYMPANOPLASTY AND MASTOIDECTOMY. IT FELL INTO THE PATIENT'S EAR AND WAS CLEARED OUT USING SUCTION. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663695 CRABTREE DISSECT JIMMY LG TIP BLADE 2MM HOOK, MICROSURGICAL EAR JYL CAREFUSION, INC AU15190 J20 10885403011580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other