BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 19956483 · Received August 9, 2024

    Report

    Report Number
    3007593722-2024-00009
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 1, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    UDI-DI
    M97026000443380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INITIATED BASED ON A REVISION SURGERY THAT WAS COMPLETED TO REMOVE A TWO DYNANAIL MINI SUBTALAR FUSION IMPLANTS WITH THE USE OF 2900-24-0250 REMOVAL CONNECTION SCREW, M2.5, DYNANAIL MINI. FROM FOLLOW-UP EMAILS AND REPORTS ON THE CASE, THERE WAS NO INFORMATION PROVIDED FOR THE REASON OF THE REVISION SURGERY. THERE WAS NO INFORMATION PROVIDED ON THE SPECIFIC PART NUMBER OF THE DYNANAIL IMPLANT. THERE WAS NO INFORMATION PROVIDED ABOUT PATIENT ADVERSE REACTIONS, ABNORMAL ANATOMY NOR IF PATIENT NON-COMPLIANCE HAD OCCURRED. THE PARTS WERE DISCARDED AT THE FACILITY SO A COMPLETE INVESTIGATION AND EVALUATION COULD NOT BE CONDUCTED. AN X-RAY IMAGE WAS PROVIDED BY THE SALES REPRESENTATIVE OF THE IMPLANT BEFORE REMOVAL. FROM THIS IMAGE, NO CONCLUSIVE STATEMENTS COULD BE MADE ABOUT THE CAUSE OF REMOVAL NOR THE FAILURE OF THE PART. POSSIBLE FACTORS FOR REQUIRING A REVISION SURGERY INCLUDE ADVERSE PATIENT REACTION, THE SCREW BACKING OUT OR A REMOVAL IN PREPARATION FOR A DIFFERENT PROCEDURE. IN REFERENCE TO THE SALESFORCE FORM COMPLETED BY THE SALES REPRESENTATIVE, IT WAS DESCRIBED THAT THE TWO REMOVAL CONNECTION SCREWS BROKE AND NEEDED REPLACEMENT. THE REMOVAL CONNECTION SCREWS WERE NOT RETURNED AND SO A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE CONDUCTED ON THIS FAILURE. THIS FAILURE MODE IS ACCOUNTED FOR IN THE RISK MATRIX (RISK-FA002-0001: MEDSHAPE ED-50300 RISK MANAGEMENT, DESIGN< DYNANAIL MINI) . THE FAILURE IS DOCUMENTED AS INSTRUMENT BREAKING/BENDING AND IS ASSIGNED A DETECTION 1, SEVERITY 3, AND OCCURRENCE 1. THE POTENTIAL CAUSE OF FAILURE IS RECORDED AS STRENGTH OF INSTRUMENTS NOT SUITABLE FOR USE. ANOTHER POSSIBLE CAUSE OF THE REMOVAL CONNECTION SCREWS' BREAKAGE COULD BE ATTRIBUTED TO IMPROPER REMOVAL TECHNIQUE, LIKE ATTEMPTING TO REMOVE THE IMPLANT WITH POWER WHICH COULD DAMAGE THE PRODUCT. HOWEVER, THE PROBABLE CAUSE REMAINS UNDETERMINED. THE RISK IS ACCOUNTED FOR IN THE MATRIX AND THUS IS AN ANTICIPATED HAZARD. THIS IS AN ISOLATED CASE, AND NO CONCLUSION COULD BE MADE REGARDING WHAT THE FAILURE MODE WAS NOR WHAT WAS THE CAUSE FOR THE REVISION SURGERY. ADDITIONALLY, NO INVESTIGATION OR EVALUATION COULD BE CONDUCTED FOR THE REPORTED REMOVAL CONNECTION SCREW BREAKAGE. THE FAILURES ARE DOCUMENTED ANTICIPATED RISKS THUS; THERE IS NO INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO DYNANAIL MINI REMOVAL CONNECTION SCREW/BOLT BROKE X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205559 ACTIVE ADAPTIVE DYNANAIL MINI HWC MEDSHAPE, INC. UNKNOWN M97026000443380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention