BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R-PILOT, 6X, STERILE

    MDR report key: 19457611 · Received June 4, 2024

    Report

    Report Number
    9611053-2024-00100
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Report Date
    July 30, 2024
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THIS EVENT WILL BE REEVALUATED, AS APPROPRIATE, IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    SIX R-PILOT FILES 25MM WERE RETURNED (ONE FILE IN LOOSE + FIVE UNUSED FILES). THE FILE IN LOOSE IS BROKEN IN THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1832596 AND #1832274). UNUSED FILES WERE EVALUATED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT R-PILOT, 6X, STERILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202573 R-PILOT, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 435792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown