BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED COMPRESSION HEADLESS SCREW

    MDR report key: 10101291 · Received May 29, 2020

    Report

    Report Number
    3012966183-2020-00004
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 18, 2020
    Report Date
    May 18, 2020
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917023749
    PMA / PMN Number
    K133842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INVESTIGATION, THERE WAS NO CAPA AND NO TRENDS ASSOCIATED WITH THIS EVENT TYPE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION, AND THEREFORE CANNOT BE EVALUATED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A DHR REVIEW COULD NOT BE PERFORMED. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF METACARPAL 3, 4, 5 DUE TO A MAL-UNION + NON-UNION FROM THE PREVIOUS PINNING. DURING THE PROCEDURE, ONE (1) TITANIUM CANNULATED COMPRESSION HEADLESS SCREW BROKE DURING INSERTION INTO THE 4TH METACARPAL. THE HEAD PORTION OF THE SCREW STUCK ON THE SCREWDRIVER FOR REMOVAL. THE SURGEON USED SCREW REMOVAL CONICAL TOOL + NEEDLE HOLDER TO BREAK OFF SECTIONS OF THE SCREW SHAFT. HALF OF THE SCREW WAS REMOVED WITH DIFFICULTY AND THE OTHER HALF OF THE SCREW REMAINED INSIDE THE 4TH METACARPAL. THE PROCEDURE WAS CONTINUED BY PLACING AN ALTERNATE PLATE TO FIX FRACTURE AROUND THE BROKEN SCREW SEGMENT. ONE (1) CORTEX SCREW SELF-TAPPING HEAD BROKE OFF DURING INSERTION. THE SCREW HEAD REMAINED ON THE SCREWDRIVER AND THE SCREW SHAFT WAS REMOVED EASILY WITH NEEDLE HOLDER. TWO (2) STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING WAS STRIPPED ON SCREW INSERTION AND ONE (1) STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING BROKE ON SCREW INSERTION. ALL PARTS OF THE BROKEN STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES FIVE (5) DEVICES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565608 CANNULATED COMPRESSION HEADLESS SCREW BONE COMPRESSION SCREW HWC TYBER MEDICAL 04.334.240 00819917023749

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention