BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN EXPLORER DE #5

    MDR report key: 480814 · Received September 2, 2003

    Report

    Report Number
    2411236-2003-10121
    Event Type
    Other
    Date Received
    September 2, 2003
    Date of Event
    August 21, 2003
    Report Date
    September 2, 2003
    Manufacturer
    WORLDSOURCE INC, HUFRIEDY MFG
    Product Code
    EKB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE EXAM BY DENTIST, THE HEAD OF THE EXPLORER SNAPPED COMPLETELY OFF AND WAS SWALLOWED BY THE PT. SENT TO E.R. FOR EVALUATION-CONFIRMED VIA X-RAY THAT TIP WAS PRESENT. 6 DAYS LATER X-RAY CONFIRMED THAT THE TIP HAD PASSED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM DISTRIBUTOR 11/14/03: THE INSTRUMENTS WERE RETURNED WITH THE TWO COMPLAINTS FOR EVLAUATION. THE TWO COMPLAINTS WERE FROM SEPARATE DOCTORS. FACILITY LOOKED AT THE FRACTURE SURFACES OF THE BROKEN INSTRUMENTS AND TOOK SOME HARDNESS VALUES OF THE TIPS. THE FRACTURE SURFACES DID NOT REALLY REVEAL MUCH FOR FACILITY'S EVALUATION. THEY APPEARED TO BE BRITTLE FAILURES, WITH NOTHING IMPLICATING A PROBLEM WITH THE MATERIAL OR STRUCTURE OF THE INSTRUMENT. THE TIPS OF THE RETURNED INSTRUMENTS ALL SEEM TO BE DIMENSIONALLY INTACT AS WELL. ALL OF THE RETURNED TIPS FALL WITHIN FACILITY'S SPECIFICATIONS RANGE. FACILITY ATTEMPTED TO DUPLICATE THE INCIDENT OF THE TIP BREAKING BY PRESSING ON A FEW THAT WERE SENT BACK UNNBROKEN WITH THE COMPLAINTS. IN ONE INSTANCE, IT TOOK EXCESSIVE FORCE TO FINALLY BREAK THE TIP OFF, AND IN ANOTHER CASE, THE TIP DID NOT BREAK OFF, IT JUST CONTINUED TO BEND BACK WHEN PRESSURE WAS APPLIED. THE TOTAL NUMBER OF PARTS RETURNED WAS FIFTEEN, THEN ADDING THE ONE FROM THIS INCIDENT MAKES SIXTEEN. THE SIXTEEN INSTRUMENTS RETURNED WERE FROM ONLY THREE DOCTORS, TWELVE INSTRUMENTS FROM ONE DOCTOR, THREE FROM ANOTHER, AND THE ONE INVOLVED HERE. THERE DOES NOT SEEM TO BE A PROBLEM WITH THE INSTRUMENTS THEMSELVES OR HOW THE INSTRUMENTS ARE MADE. THERE ARE ISOLATED INCIDENTS, THE REASON FOR THE TIPS BREAKING IS A PROBABLE USER ERROR IN THE AMOUNT OF FORCE THAT THEY ARE APPLYING WHEN USING THIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN EXPLORER DE #5 * EKB WORLDSOURCE INC, HUFRIEDY MFG * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other