BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE METAL SCREWDRIVER BODY

    MDR report key: 22629509 · Received July 28, 2025

    Report

    Report Number
    2027754-2025-00031
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 22, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HXX
    PMA / PMN Number
    K111176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PARTS WERE RECEIVED ON 9/16/2025. FOR THE 220-0262 SCREWDRIVER HANDLE THE BATCH # IS CONFIRMED, BASED ON UDI. THE MOVEMENT OF THE SS PART WITH STRAIGHT KNURLS WAS AS DESCRIBED ON COMPLAINT, VERY HARD TO ROTATE, THAT IS A FAILURE. THE ROOT CAUSE OF THIS FAILURE COULDN'T BE CONFIRMED WITHOUT DISASSEMBLING THE UNIT, SO NO ACTION ITEM IS RECOMMENDED. NO DEFINITIVE CONCLUSION CAN BE MADE.

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE. MDRS FOR THIS COMPLAINT: 2027754-2025-00029 TO 31.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SCREWS BROKE OFF WHILE DR WAS TRYING TO SECURE THEM INTO THE BONE FLAP AS WELL AS PART OF THE SCREWDRIVER DID NOT ROTATE. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773531 BLUE METAL SCREWDRIVER BODY SCREWDRIVER HXX OSTEOMED, LLC 220-0262 1167947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown