BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASOR DRILL

    MDR report key: 21866668 · Received April 18, 2025

    Report

    Report Number
    3016577622-2025-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Report Date
    April 18, 2025
    Manufacturer
    PHASOR HEALTH, LLC
    Product Code
    HBE
    UDI-DI
    B775450K0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. PHASOR HEALTH'S DRILLS HAVE BEEN 100% INSPECTED FOR VARIOUS ATTRIBUTES THROUGH MANUFACTURING, AND THE POLARITY OF THE DRILL IS DEPENDENT UPON BATTERY INSERTION IN THE CORRECT ORIENTATION. THEREFORE, A PROBLEM WITH ONE DRILL DOES NOT SUGGEST A PROBLEM WITH THE LOT AS A WHOLE. 2. PHASOR HEALTH REVIEWED THE FREQUENCY OF UNITS FOUND WITH REVERSED POLARITY AS PART OF IN-PROCESS INSPECTION, FINAL INSPECTION, AND PRODUCT COMPLAINTS AFTER DISTRIBUTION. THE OVERALL FREQUENCY IS LESS THAN 1:2,000. 3. PHASOR HEALTH INITIATED A COMPLAINT INVESTIGATION. ONE ADDITIONAL UNIT WAS IDENTIFIED DURING IN-PROCESS INSPECTION PRIOR TO FINAL INSPECTION, PACKAGING, AND STERILIZATION, WITH ONE OTHER UNIT FOUND ON POST-USE ANALYSIS THUS FAR. NO UNITS WERE FOUND AT THE FINAL INSPECTION OTHERWISE. 4. MULTIPLE CUSTOMERS RECEIVED "4.50K LOT: 241030450," BUT ONLY THE SITE WITH THE ORIGINAL COMPLAINT REPORTED THE ISSUE. 5. DIRECT CORRESPONDENCE WOULD OF COURSE AID PATIENT CARE BEST (AIDING SAFETY WHILE LIMITING UNNECESSARY MEASURES). 6. PHASOR HEALTH INITIATED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THE ORIGINAL COMPLAINT, AND ONE ADDITIONAL SUCH SPECIFIC COMPLAINT HAS BEEN RECEIVED -- A REVERSAL OF BATTERY PLACEMENT APPEARS THE ROOT CAUSE, WITH CORRECTIONS INCLUDING REPLACEMENT OF THE FEW AFFECTED DRILLS, AND CORRECTIVE ACTION OF SECONDARY INSPECTION OF CORRECT POLARITY INSTITUTED AS PART OF THE MANUFACTURING PROCESS. 7. A DRILL WITH REVERSED POLARITY "MAY CAUSE [THE DRILL] TO OPERATE IN THE OPPOSITE DIRECTION THAN INTENDED. IF THIS OCCURS, OPTIONS INCLUDE REVERSING THE SWITCH SO THAT THE DRILL OPERATES CLOCKWISE (AND DRILLS CORRECTLY IN REVERSE VS. FORWARD), OR UTILIZING ANOTHER DRILL, POSSIBLY DELAYING THE SURGICAL PROCEDURE." 8. NO HARM HAS OCCURRED OR IS EXPECTED TO OCCUR FOR THIS ISSUE IF IT WERE TO RECUR; HOWEVER, AS NO OTHER RECENT LOTS APPEAR AFFECTED, AND WITH THE LIMITED COMPLAINTS AS NOTED, THIS ISSUE APPEARS CONTAINED.

    Description of Event or Problem · 0

    1. SWITCH ACTIVATION OF LOT: 241030450 OF PHASOR HEALTH 4.50K FIXED DISPOSABLE CRANIAL ACCESS DRILLS MAY CAUSE THEM TO OPERATE IN THE OPPOSITE DIRECTION THAN INTENDED. 2. IF THIS OCCURS, ANOTHER DRILL WILL BE NECESSARY, POSSIBLY DELAYING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911615 PHASOR DRILL PHASOR DRILL HBE PHASOR HEALTH, LLC 4.50K 241030450 B775450K0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown