BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM

    MDR report key: 18160464 · Received November 17, 2023

    Report

    Report Number
    3012966183-2023-00024
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 7, 2023
    Report Date
    November 17, 2023
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917027495
    PMA / PMN Number
    K192975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVENT THOUGH NOT A TYBER MEDICAL DEVICE ISSUE IS REPORTABLE PER THE SURGICAL DELAY OF 30 MINUTES. THE DELAY CAUSED A WOUND DELAY OF HEALING. PART NUMBER 310.221 IS NOT A TYBER MEDICAL DEVICE WHICH FRACTURED AND CAUSED THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    PERFORMED AN IPJ FUSION USING CCHS. THIS INSTRUMENT SET USED WAS THE SET ON THE SHELF THAT CONTAINED THE REUSABLE 2.0MM DRILL BIT (310.221). WHEN DRILLING FOR THE SCREW THE DRILL BIT BROKE INTO PIECES. BITS WERE REMOVED AS BEST AS POSSIBLE AND FRESH DRILL BIT WAS USED FROM ANOTHER KIT. SCREW WAS INSERTED SUCCESSFULLY. ON FINAL X- RAYS THERE WAS NOT VISIBLE REMNANTS OF THE BROKEN DRILL BIT. WHEN GUIDE WIRE WAS REMOVED IT WAS IDENTIFIED TO HAVE A SLIGHT BEND TO IT. IF OTHER, DESCRIBE IPJ FUSION LEFT SIDE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 30 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? METAL ITEMS WERE REMOVED , WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, IF NO, EXPLAIN: ITEMS WERE REMOVED USING VARIOUS INSTRUMENTS. AS MENTIONED ON FINAL X-RAY NO FRAGMENTS WERE VISIBLE, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE EXTRA TIME AND X-RAYS USING FLUOROSCOPY WERE NEEDED, IS THE PATIENT PART OF A CLINICAL STUDY NO, IP(B)(4) DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OF BIN BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.TRUE THIS COMPLAINT INVOLVES ONE(1) DEVICE. 2.0MM DRILL BIT (310.221) IS NOT A TYBER MEDICAL PART NUMBER NEW INFO FROM SURGEON: PATIENT SEEN BY DR. FISHER. SCREW HAS MIGRATED SLIGHTLY AND DRILL BIT FRAGMENT IDENTIFIED. DR FISHER STATED THAT THE PATIENT WAS CURRENTLY HAPPY AND WOULD SEE HIM AGAIN IN 4 WEEKS. IF REVISION SURGERY IS HAPPY DR FISHER WILL REMOVE DRILL FRAGMENT AT THAT TIME. IF NOT, HE HAS STATED THAT HE WILL LEAVE IT WHERE IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744261 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM SCREW HWC TYBER MEDICAL 04.333.226TS 224165 00819917027495

    Patients

    Seq Age Sex Outcome Treatment
    1 Male