BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 11776380 · Received May 5, 2021

    Report

    Report Number
    3011421599-2021-00005
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    October 13, 2020
    Report Date
    April 26, 2021
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027149
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL BUNION CORRECTION WAS PERFORMED ON (B)(6) 2020 WITH NO CROSSROADS PRODUCTS USED. THE BUNION CORRECTION WAS REVISED ON (B)(6) 2020 USING THE CROSSROADS MINIBUNION SYSTEM FOR FIXATION OF THE BUNION CORRECTION. THE SURGEON REPORTS THE NON-LOCKING SCREW FAILED. X-RAY EVIDENCE REVEALS THAT THE NON-LOCKING SCREW MISSED THE LATERAL CORTEX OF THE 1ST METATARSAL SHAFT AND WAS FLOATING IN THE OSTEOTOMY SITE INTRAOPERATIVELY. NO NON-CONFORMANCES WERE IDENTIFIED IN REVIEW OF MANUFACTURING RECORDS. SCREW BACK-OUT MAY BE DUE TO INADEQUATE FIXATION INTRA-OPERATIVELY. MINIBUNION SCREWS WERE REMOVED IN ADDITION TO THE PLATE: REF: 3100-0030, LN: 501225, QTY: 1 PRODUCT NAME: MINIBUNION 3.5MM OFFSET PLATE SHORT. REF: 3100-3022LK, LN: 500729, QTY: 1 PRODUCT NAME: MINIBUNION LOCKING SCREW 3.0MM X 22MM. REF: 3100-2720NL, LN: 501024, QTY: 1 PRODUCT NAME: MINIBUNION NON-LOCKING SCREW 2.7MM X 20MM.

    Description of Event or Problem · 1

    A BUNION CORRECTION WAS REVISED ON (B)(6) 2020 USING THE CROSSROADS MINIBUNION SYSTEM FOR FIXATION OF THE BUNION CORRECTION. THE SURGEON REPORTS THE NON-LOCKING SCREW FAILED. X-RAY EVIDENCE REVEALS THAT THE NON-LOCKING SCREW MISSED THE LATERAL CORTEX OF THE 1ST METATARSAL SHAFT AND WAS FLOATING IN THE OSTEOTOMY SITE INTRAOPERATIVELY. BUNION CORRECTION WAS REVISED ON (B)(6) /2020 USING THE CROSSROADS MINIBUNION SYSTEM FOR FIXATION OF THE BUNION CORRECTION. THE SURGEON REPORTS THE NON-LOCKING SCREW FAILED. X-RAY EVIDENCE REVEALS THAT THE NON-LOCKING SCREW MISSED THE LATERAL CORTEX OF THE 1ST METATARSAL SHAFT AND WAS FLOATING IN THE OSTEOTOMY SITE INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674595 MINIBUNION PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 501225 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention