BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY KIRKLAND KNIFE

    MDR report key: 1884993 · Received October 21, 2010

    Report

    Report Number
    1416605-2010-00003
    Event Type
    Other
    Date Received
    October 21, 2010
    Date of Event
    January 25, 2010
    Report Date
    October 21, 2010
    Manufacturer
    HU-FRIEDY MFG. CO.,INC.
    Product Code
    EIX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT OF PATIENT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFORMATION. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT WAS A (B)(4) INSTRUMENT THAT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. DR. (B)(6) RETURNED A GROUP OF INSTRUMENTS TO HU-FRIEDY FOR REPLACEMENT AND THE BROKEN KK15/16 KIRKLAND KNIFE WAS INCLUDED IN THAT RETURN WITHOUT ANY INDICATION THAT IT WAS A DEVICE WHICH HAD BROKE IN A PATIENT MOUTH AND WAS INVOLVED IN AN ADVERSE EVENT. OUR TECHNICAL SERVICES DEPARTMENT REPLACED HIS INSTRUMENTS AND DISPOSED OF THE RETURNED INSTRUMENTS PER STANDARD PROCEDURE. AT THE SAME TIME, A SEPARATE RETURN NOTIFICATION WAS OPENED IN OUR SYSTEM AND WAS AWAITING THE RETURN OF THIS INSTRUMENT WHICH CLEARLY DESCRIBED THAT WE WERE AWAITING AN INSTRUMENT INVOLVED IN AN ADVERSE EVENT. THAT NOTIFICATION REMAINED OPEN AND UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE INSTRUMENT WAS ALREADY RETURNED WITH ANOTHER GROUP OF INSTRUMENTS. BY THE TIME THIS WAS DISCOVERED, THE INSTRUMENT COULD NOT BE RECOVERED FOR EVALUATION. QUALITY RETURNS FOR THIS DEVICE ARE VERY LOW, APPROXIMATELY (B)(4) PER YEAR AND NO PREVIOUS ADVERSE EVENTS WITH THIS PRODUCT HAVE BEEN REPORTED. NO FURTHER INVESTIGATION WAS CONDUCTED BY HU-FRIEDY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, HU-FRIEDY'S QUALITY ASSURANCE MANAGER WAS INFORMED BY DR. (B)(6) THAT A MALE PATIENT IN HIS (B)(6) WAS HAVING A GINGIVOPLASTY PERFORMED WHEN THE END OF A HU-FRIEDY KIRKLAND KNIFE FRACTURED. THE PATIENT HAD A REFLEXIVE REACTION AND SWALLOWED THE TIP OF THE BLADE. DR. (B)(6) SENT THE PATIENT TO A GASTROENTEROLOGIST, WHO REMOVED THE FRACTURED END OF THE KNIFE FROM THE PATIENT VIA AN ENDOSCOPY. DR. (B)(6) REPORTS THAT THE PATIENT IS DOING FINE AND HAD NO FURTHER COMPLICATIONS. THE INCIDENT TOOK PLACE ON (B)(6) 2010. DR. (B)(6) DID NOT INFORM HU-FRIEDY AT THE TIME OF THE INCIDENT BECAUSE THE PATIENT HAD NO COMPLICATIONS. DURING A ROUTINE VISIT FROM A HU-FRIEDY SALES REPRESENTATIVE, THE DOCTOR MENTIONED THE INCIDENT AND THE HU-FRIEDY SALES REPRESENTATIVE SENT THE INFORMATION OVER TO THE QUALITY DEPARTMENT FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY KIRKLAND KNIFE KK15/16 EIX HU-FRIEDY MFG. CO.,INC. KK15/16 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention WITH MEDICAL PRODUCTS| PATIENT DID NOT REQUIRE ANY THERAPY OR TREATMENT