BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY SWIVEL DIRECT FLOW STRAIGHT FLOW STRAIGHT 30KHZ

    MDR report key: 1635477 · Received March 15, 2010

    Report

    Report Number
    1416605-2010-00001
    Event Type
    Other
    Date Received
    March 15, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 15, 2010
    Manufacturer
    HU-FRIEDY MFG, INC.
    Product Code
    ELC
    PMA / PMN Number
    K012060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HU-FRIEDY TECHNICAL CARE SUPERVISOR RECEIVED A PHONE CALL FROM (B)(6) AND AN E-MAIL FROM (B)(6) DESCRIBING AN ADVERSE EVENT INVOLVING A HU-FRIEDY ULTRASONIC INSERT THAT OCCURRED ON (B)(6) 2010 AND INVOLVED A FEMALE CLIENT (PT). THIS INSTRUMENT WAS RETURNED TO US ON (B)(6) 2010 AND WAS EVALUATED BY A QUALITY ASSURANCE ENGINEER. THE RESULTS ARE AS FOLLOWS. RETURNED INSERT WAS BROKEN AT THE APERTURE OF THE EDM HOLE. RETURNED INSERT BROKE AT APPROXIMATELY 9.5MM FROM THE TIP. HARDNESS FOUND TO BE 49RC. SPECIFICATIONS ARE 48-52RC. MET THE SPECIFICATION REQUIREMENT, WHICH INDICATES THAT THE INSERT WAS PROPERLY HEAT TREATED. DIMENSIONS: DIAMETER OF THE DEVICE AT THE FRACTURE SURFACE MET THE SPECIFICATION REQUIREMENT. FRACTURE SURFACE RESEMBLES THAT A TYPICAL FATIGUE FAILURE. THERE ARE STRIATION MARKS AROUND THE EDM HOLE. CONCLUSION: AS PER THE TELEPHONE CONVERSATION/E-MAIL DATED (B)(6) 2010 BETWEEN HU-FRIEDY AND (B)(6) THE RETURNED INSTRUMENT WAS USED ON THE HIGH POWER SETTING WHEN IT BROKE DOWN IN THE CLIENT'S MOUTH. AS PER HU-FRIEDY USER MANUAL FOR (B)(4) ULTRASONIC INSERT SHOULD BE USED ON A LOW TO MEDIUM POWER SETTING ONLY. (B)(6) WAS NOT ABLE TO PROVIDE US WITH PTS INFO. WE TRACK OUR DEVICES BY LOT # (DATE CODE). THE PRODUCT INVOLVED IS (B)(4) INSTRUMENT THAT DOES NOT HAVE A EXP DATE. THE DEVICE IS NOT IMPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, HU-FRIEDY BECAME AWARE OF THE FOLLOWING EVENT. DURING A PROCEDURE PERFORMED ON (B)(6) 2010 AT (B)(6) ON A PT USING A HU-FRIEDY INSTRUMENT # (B)(4) DATE CODE Q9 ((B)(6) 2009). THE INSTRUMENT TIP HAD BROKEN OFF (APPR. 2MM X 7MM CURVED WITH A POINT) IN THE CLIENT'S MOUTH. WE WERE INFORMED THAT OPERATOR HAD NOT BEEN ABLE TO FIND THE TIP. AN ORAL INSPECTION HAD BEEN COMPLETED, AND IMMEDIATE OPERATOR'S AREA WAS SEARCHED. TIP WAS NOT FOUND DURING THE SEARCH. IN CONVERSATIONS WITH THE PT, THEY FOUND OUT THAT THE PT THOUGHT THAT SHE HAD SWALLOWED THE TIP. A PANOREX RADIOGRAPH WAS EXPOSED AND REVIEWED BY THE ATTENDING DENTIST, CONFIRMED THAT THE TIP WAS NOT LOCATED IN THE ORAL CAVITY OF THE CLIENT. THE CLIENT REPORTED FOR X-RAY AT (B)(6). THE CLIENT WAS TOLD THE TIP WAS IN HER STOMACH AND THAT IT WOULD BE NECESSARY TO SURGICALLY REMOVE THE TIP BY ENDOSCOPIC PROCEDURE. ANOTHER X-RAY WAS PERFORMED BEFORE THE PROCEDURE. ENDOSCOPIC PROCEDURE WAS PERFORMED BUT IT WAS NOT SUCCESSFUL IN RETRIEVING THE INSTRUMENT TIP. THE CLIENT WAS RELEASED WITH NO F/U SERVICES RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY SWIVEL DIRECT FLOW STRAIGHT FLOW STRAIGHT 30KHZ ELC-ULTRASONIC INSERT ELC HU-FRIEDY MFG, INC. UI30SDS Q9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NO CONCOMITANT MEDICAL PRODUCTS WERE IN USE AND| HU-FRIEDY.| THERE ARE NO APPLICABLE THERAPY WERE INFORMED TO