BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION COMPRESSON¿ SCREW

    MDR report key: 23288967 · Received October 15, 2025

    Report

    Report Number
    3003407235-2025-00012
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 23, 2025
    Report Date
    September 23, 2025
    Manufacturer
    INION OY
    Product Code
    HWC
    UDI-DI
    06438408008122
    PMA / PMN Number
    K203105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELATED TO THIS PRODUCT BATCH, AND THE BATCH RECORDS SHOW THAT THE PRODUCT BATCH IS IN SPECIFICATION. IT HAS BEEN OBSERVED THAT THERE IS A LEARNING CURVE ASSOCIATED WITH THE INSERTION OF THE INION COMPRESSION SCREWS DUE TO THE MINIMIZED AMOUNT OF MATERIAL. OVERALL, THIS WAS A CHALLENGING FRACTURE AND THE BONE QUALITY IN THE DIAPHYSIS WAS EXTREMELY HARD.

    Description of Event or Problem · 0

    TWO INION COMPRESSON SCREWS (2.7*12 MM) WERE USED TO FIX METACARPAL FRACTURES IN A 17-YEAR-OLD PATIENT. THE FOURTH METACARPAL BONE HAD A FRACTURE AT THE DIAPHYSIS, AND IT WAS DIFFICULT TO ALIGN THE ENDS OF THE BONES. WHILE THREADING THE SCREW HOLE, A SMALL PIECE OF BONE BROKE OFF. THIS DID NOT IMPACT THE PLANNED OPERATION AND AFTER THREADING, THE SURGEON STARTED INSERTING ONE INION COMPRESSON SCREW TO THE THREADED SCREW HOLE. HOWEVER, DURING INSERTION, THE SCREW HEAD BROKE WHEN IT HIT THE SURFACE OF THE BONE AND THE SCREW WOULD NO LONGER TURN. THE SCREW WAS LEFT IN PLACE AND ITS HEAD WAS CUT OFF WITH CUTTERS. THE FRACTURE WAS FINALLY REPAIRED WITH CERCLAGE METAL WIRE AND ONE TRANSVERSE K-WIRE. THE SURGERY TOOK APPROXIMATELY 30 MINUTES LONGER, INCLUDING THE INSTALLATION OF THE METAL WIRE AND K-WIRE. THE FRACTURE AT THE DISTAL END OF THE THIRD METACARPAL (MIDDLE FINGER BONE) WAS SUCCESSFULLY FIXED WITH THE INION COMPRESSON SCREW. THE SURGEON WAS SATISFIED WITH THE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482560 INION COMPRESSON¿ SCREW BONE SCREW HWC INION OY 1 2301013 06438408008122

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown Required Intervention CERCLAGE METAL WIRE (UNKNWON MANUFACTURER)| K-WIRE (UNKNOWN MANUFACTURER)