BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW PIN WITH STOP 3,2MM X 30MM

    MDR report key: 24208165 · Received January 29, 2026

    Report

    Report Number
    3012523063-2026-00007
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 29, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE EVENT DESCRIPTION, A SCREW PIN WITH STOP FRACTURED DURING REGULAR USE. THE PRODUCT IN CONCERN HAS NOT BEEN SENT BACK TO IMPLANTCAST GMBH. A PHOTO OF THE BROKEN SCREW PIN WITH STOP WAS PROVIDED BY THE CUSTOMER, ENABLING A LIMITED OPTICAL EXAMINATION. HOWEVER, THE FRACTURE SURFACE ITSELF IS NOT VISIBLE ON THIS PHOTO. SINCE NO LOT NUMBER WAS REPORTED, NEITHER MATERIAL CERTIFICATES NOR MANUFACTURING DOCUMENTS COULD BE CHECKED. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO TECHNICAL ROOT CAUSE OF THE FRACTURE COULD BE DETERMINED. IT CAN ONLY BE AS-SUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT. IT CANNOT BE DETERMINED HOW LONG THE SCREW PIN WAS IN USE WHEN THE FRACTURE OCCURRED. ANOTHER FACTOR FOR SUCH A FRACTURE IS THE DENSITY OF THE BONE. HOWEVER, THIS INFORMATION WAS NOT PROVIDED. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE PIN SHEARED OFF JUST ABOVE THE STOP WHILST GETTING DRILLED INTO PLACE." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, IT HAD NO ADVERSE IMPACT ON THE PATIENT'S HEALTH AND DID NOT LEAD TO AN EXTENSION OF THE SURGERY TIME. AN ALTERNATIVE PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271907 SCREW PIN WITH STOP 3,2MM X 30MM SCREW PIN WITH STOP LXH IMPLANTCAST GMBH 42240136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other