BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHG SKN ORAL NSL KIT W/CORINZ

    MDR report key: 20887925 · Received December 9, 2024

    Report

    Report Number
    0001419181-2024-00014
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 23, 2025
    Manufacturer
    SAGE PRODUCTS LLC
    Product Code
    EFW
    UDI-DI
    00618029791399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT INFORMATION AND THE AFFECTED DEVICE WERE RETURNED FOR EVALUATION. A VISUAL/FUNCTIONAL INSPECTION WAS PERFORMED ON THE AFFECTED DEVICE BY THE STRYKER QUALITY ENGINEER. ALL 38 TUFTS ARE PRESENT ON THE TOOTHBRUSH HEAD, AND IT DID NOT APPEAR THAT BRISTLES WERE MISSING WITHOUT MAGNIFICATION. A PRODUCT HISTORY REVIEW WAS PERFORMED FOR THE IMPLICATED DEVICE AND LOT NUMBER. ALL QUALITY CHECKS PERFORMED DURING THE STRYKER MANUFACTURING PROCESS INDICATED PASSING RESULTS AND ALL RELEASE CRITERIA WERE MET PER THE PRODUCT DRAWING. THE ULTRA-SOFT TOOTHBRUSH IS MANUFACTURED AT A THIRD-PARTY SUPPLIER AND INSPECTED AT INCOMING QUALITY ASSURANCE (IQA) AT STRYKER CARY PRIOR TO BEING USED IN THE MANUFACTURING PROCESS. IQA RECORDS INDICATE INDICATED PASSING RESULTS FOR ALL ATTRIBUTES. THE THIRD-PARTY MANUFACTURER WAS CONTACTED REGARDING THIS REPORT. THEY PERFORMED A DEVICE HISTORY RECORD REVIEW. THE BATCH RECORDS FOR THE RAW MATERIALS OF TWO OUT OF FOUR LOTS REVIEWED SHOW EVIDENCE OF POTENTIAL PROBLEMS WITH THE PRODUCT. ALL TESTS PASSED ACCEPTANCE CRITERIA, EXCEPT FOR VISUAL FINDINGS. THESE FINDINGS INDICATED THERE WERE INSTANCES OF STRAY, DAMAGED AND MISSING NYLON WITHIN THE AFFECTED LOTS. ADDITIONALLY, A HIGH STAPLE WAS NOTED WITHIN ONE OF THE AFFECTED LOTS. THE THIRD-PARTY MANUFACTURER INITIATED A NONCONFORMANCE RELATED TO THOSE FINDINGS. THE THIRD-PARTY MANUFACTURER ALSO THOROUGHLY INSPECTED THE AFFECTED TOOTHBRUSH. WITH MAGNIFICATION, SOME OF THE STAPLES APPEARED TO HAVE TWISTED AFTER ENTERING THE TUFT HOLE. TUFT RETENTION FORCES FOR TUFT 35 WERE NOT WITHIN SPECIFICATION. ADDITIONALLY, SHORT, APPARENTLY ¿BROKEN¿ FIBERS WERE IDENTIFIED. THE BOTTOM PORTION (PORTION THAT RESIDES IN THE TUFT HOLE, UNDER THE STAPLE) OF THESE FIBERS WAS FOUND, FURTHER INDICATING THAT THE FIBERS WERE BREAKING MID-STRAND. WHEN THE FIBERS WERE INSPECTED UNDER MAGNIFICATION, NUMEROUS FIBERS WERE IDENTIFIED THAT APPEARED TO BE SMASHED, ABRADED, OR CUT. THE THIRD-PARTY MANUFACTURER WAS UNABLE TO IDENTIFY A ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REPORT RECEIVED OF A TOOTHBRUSH BRISTLE DISENGAGEMENT. REPORTER STATED ON (B)(6) 2024, AN ALERT AND ORIENTED 65-YEAR-OLD FEMALE PATIENT OF NORMAL AFFECT USED AN ULTRA-SOFT TOOTHBRUSH FROM THE #9010 NOSE TO TOES ORAL CARE KIT, TO INDEPENDENTLY BRUSH HER TEETH BEFORE AN ORTHOPEDIC SURGERY. THE REPORTER STATED THE EVENT OCCURRED ON INITIAL USE OF THE DEVICE AND THAT THE BRISTLES FROM THE TOOTHBRUSH DISENGAGED INTO PATIENTS¿ MOUTH "IN CLUMPS". THE REPORTER STATED THE PATIENT HAD NO BRACES OR ORAL HARDWARE IN PLACE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. PER THE REPORTER, THE PATIENT WAS ABLE TO REMOVE ALL THE BRISTLES INDEPENDENTLY BY RINSING HER MOUTH OUT AND EXPECTORATING THE BRISTLES OR PULLING THEM OUT. THE PATIENT'S SURGERY WENT FORWARD AS PLANNED WITHOUT DELAY AND THE PATIENT HAD NO ADVERSE CONSEQUENCES. NO PHOTOS WERE TAKEN OF THE AFFECTED TOOTHBRUSH. LOT INFORMATION WAS PROVIDED. THE AFFECTED DEVICE WAS RETURNED TO SAGE FOR PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537278 CHG SKN ORAL NSL KIT W/CORINZ MANUAL TOOTHBRUSH EFW SAGE PRODUCTS LLC 9010 98789 00618029791399

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female