BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM2.7MM B/T/B XPIN

    MDR report key: 11764295 · Received May 3, 2021

    Report

    Report Number
    1221934-2021-01414
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 30, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705000883
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE 2.7 MM RIGIDFIX BTB CROSSPIN KIT REF 210127 LOT NO.7L24411 IS FAULTY. THE DEVICE WAS RECEIVED AND EVALUATED. THE 2 SLEEVES AND THE TROCAR WERE RETURNED, WHICH ARE PART OF THE SAME KIT. UPON VISUAL INSPECTION, THE SLEEVE AND THE TROCAR WERE FOUND JAMMED, IT COULD BE OBSERVED STRETCH MARKS ALL OVER THE SLEEVE, ALSO ON THE TROCAR. THESE ITEMS ARE JAMMED, IT IS NOT POSSIBLE TO SEPARATE THEM. THE 2 CROSS PINS WERE NOT RETURNED A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 7L24411 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE JAMMED CONDITION CAN BE ATTRIBUTED TO A MISHANDLING OF THE DEVICE. CONSIDERING THAT THE SLEEVE AND THE TROCAR HAS THE STRETCH MARKS, WE CAN RELATE THIS ISSUE TO A BAD AXIS ALIGNMENT OF THE DRILL AT THE MOMENT OF INSERTION, THE BENDING FORCE APPLIED AND THE HIGHER SPINNING SPEED OF THE DRILL CAN CONTRIBUTE TO THE JAMMING CONDITION OF THE SLEEVE AND THE TROCAR. AS PER IFU 106938: DIRECTIONS FOR A SUCCESSFULLY HOLE DRILLING AND TROCAR AND SLEEVE INTERACTION ARE PROVIDED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SLEEVE AND THE TROCAR WERE FOUND JAMMED ON THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656528 RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210127 10886705000883

    Patients

    Seq Age Sex Outcome Treatment
    1