BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBS

    MDR report key: 24647073 · Received March 20, 2026

    Report

    Report Number
    3010470577-2018-12231
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    December 14, 2018
    Report Date
    March 19, 2026
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    UDI-DI
    03760225710173
    PMA / PMN Number
    K131920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Additional Manufacturer Narrative · 0

    THE EVALUATION WAS PERFORMED USING THE INFORMATION CONTAINED IN THE ORIGINAL COMPLAINT FILE AND THE MATERIALS RETURNED AT THE TIME OF THE EVENT. A VISUAL INSPECTION OF THE RETURNED COMPONENTS WAS CONDUCTED. THE 2.5 MM SCREW EXHIBITED A MID SHAFT FRACTURE. THE PROXIMAL PORTION WAS FOUND TWISTED AROUND THE GUIDE K-WIRE, WHILE THE K-WIRE ITSELF REMAINED INTACT. THE FRACTURE SURFACE SHOWED SIGNS CONSISTENT WITH THE CONDITION OF THE PRODUCT AT THE TIME OF RECEIPT. ACCORDING TO THE INFORMATION PROVIDED, DURING AN IPD ARTHRODESIS PROCEDURE THE GUIDE K-WIRE WAS POSITIONED AND THE SCREW WAS INSERTED USING POWERED INSTRUMENTATION. DURING INSERTION, THE SCREW BEGAN TO WRAP AROUND THE K-WIRE RATHER THAN ADVANCE NORMALLY, RESULTING IN MECHANICAL OVERLOAD AND SUBSEQUENT FRACTURE OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED WITHOUT ANY REPORTED PATIENT INJURY. A REVIEW OF THE AVAILABLE PRODUCTION RECORDS FOR LOT 1803063 AND OF-500714-020 CONFIRMED THAT ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE. NO DEVIATIONS OR ANOMALIES WERE RECORDED IN RELATION TO THIS PRODUCT. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS CONSISTENT WITH MECHANICAL OVERLOAD DURING INSERTION. NO CORRECTIVE OR REMEDIAL ACTIONS HAVE BEEN IDENTIFIED FROM THE DOCUMENTATION AVAILABLE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, AN IBS 2.5 SCREW BROKE AT ITS MID SECTION. THE SURGEON INSERTED A GUIDE WIRE FOR AN IPD ARTHRODESIS AND ATTEMPTED TO INSERT THE IBS 2.5 SCREW WITH THE MOTOR DRIVER. THE SCREW TWISTED AROUND THE GUIDE WIRE AND FRACTURED, RESULTING IN AN APPROXIMATE 25 MINUTE SURGICAL DELAY.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, AN IBS 2.5 SCREW BROKE AT ITS MID SECTION. THE SURGEON INSERTED A GUIDE WIRE FOR AN IPD ARTHRODESIS AND ATTEMPTED TO INSERT THE IBS 2.5 SCREW WITH THE MOTOR DRIVER. THE SCREW TWISTED AROUND THE GUIDE WIRE AND FRACTURED, RESULTING IN AN APPROXIMATE 25 MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201527 IBS IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7 HWC IN2BONES SAS S25 ST028 1803063 03760225710173

    Patients

    Seq Age Sex Outcome Treatment
    1