BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES III STRAIGHT DRILL

    MDR report key: 13242769 · Received January 12, 2022

    Report

    Report Number
    2027754-2022-00005
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    August 18, 2020
    Report Date
    January 12, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    KMW
    UDI-DI
    00845694037167
    PMA / PMN Number
    K971692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED LATE BECAUSE OF AN OVERSIGHT DURING THE INVESTIGATION OF THIS COMPLAINT IN 2020 AND SUBSEQUENT RECENT REVIEW OF COMPLAINTS DUE TO NEW MANAGEMENT AND POSTMARKET PERSONNEL DETERMINED THIS COMPLAINT IS MDR REPORTABLE. TWO DRILLS WERE RETURNED FOR COMPLAINT #: (B)(4)- THIS MDR IS FOR ONE OF THE DRILLS. THE OTHER DRILL WAS REPORTED UNDER 2027754-2022-00004. THE FOLLOWING IS THE INVESTIGATION PERFORMED AT THE TIME OF THIS COMPLAINT IN 2020: TWO SERIES III STRAIGHT DRILLS WERE RETURNED FOR EVALUATION AND REPAIR. THE WORK ORDER FOR REPAIR INDICATED THE ISSUE WAS CAUSED BY WORN AND DIRTY BEARINGS. INVENTORY REVIEW WAS PERFORMED WHICH INCLUDED 78PCS OF LOT NUMBERS 1156259(30PCS), 1154093(30PCS) AND 1151367(18PCS). THERE WERE NO NON-CONFORMITIES FOUND DURING INVENTORY REVIEW PROCESS. THERE WERE NO CAPAS AND TWO NCR'S INITIATED FOR PART NUMBER 450-0777 DURING 2018-PRESENT TIMEFRAME. THE TWO NCRS WERE UNRELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON 18 AUGUST 2020, THE FACILITY OFFICE MANAGER REPORTED THEY HAD TWO MACHINES THAT WERE GETTING HOT AND BURNING THE MUCOSA IN THE PATIENT'S MOUTHS. IT WAS REPORTED THERE WAS NO PATIENT HARM, AND NO TREATMENT OR MEDICAL INTEVENTION WAS NECESSARY AS A RESULT OF THE BURNS. THIS REPORT IS FOR ONE OF THE DEVICES ASSOCIATED WITH COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701842 SERIES III STRAIGHT DRILL HANDPIECE, ROTARY BONE CUTTING KMW OSTEOMED, LLC 450-0777 00845694037167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown