BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT SYSTEM, MPFL

    MDR report key: 3113007 · Received May 15, 2013

    Report

    Report Number
    1220246-2013-00078
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. COMPLAINT EVALUATION REVEALED BROKEN DISTAL END OF SCREW. FROM THE EVENT DESCRIPTION, IT IS UNCLEAR IF THE IMPLANT BROKE UPON INSERTION OR POST-OP. AN IMPLANT BREAKING DURING INSERTION IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. THE MOST LIKELY CAUSE OF THE IMPLANT BREAKING POST-OP IS DAMAGE TO THE IMPLANT DURING INSERTION, IMPROPER PLACEMENT IN THE TUNNEL OR POST-OP PATIENT NON-COMPLIANCE. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INITIAL MPFL RECONSTRUCTION ON (B)(6) 2012. AFTER A BROKEN SCREW WAS DETECTED DURING AN MRI, THE SWIVELOCK ANCHOR WAS REMOVED BY REVISION SURGERY ON (B)(6) 2013. NO FURTHER INFORMATION GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215535 IMPLANT SYSTEM, MPFL FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other