BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAFIX

    MDR report key: 20178088 · Received September 10, 2024

    Report

    Report Number
    9614209-2024-00374
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 26, 2024
    Manufacturer
    CORIN LTD
    Product Code
    JDI
    PMA / PMN Number
    K082525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER (B)(4) INITIAL REPORT. THE REPORTED METAFIX STRAIGHT STEM PUNCH IS BEING RETURNED AND WILL BE EXAMINED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    PER -7664 FINAL REPORT. THE REPORTED METAFIX STRAIGHT STEM PUNCH WAS RETURNED AND EXAMINED. THE ASSOCIATED METAFIX COLLARED STEM WAS NOT RETURNED AND THUS THE PARTS COULD NOT BE FUNCTIONALLY CHECKED TOGETHER TO VERIFY THIS REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. ADDITIONALLY, CORIN HAS NOT RECEIVED ANY OTHER REPORTS RELATING TO DEVICES FROM THESE BATCHES. EXAMINATION OF THE METAFIX STRAIGHT STEM PUNCH IDENTIFIED DAMAGE AND SLIGHT BURRING OF THE CONNECTION END THAT INSERTS INTO THE STEM. THIS DAMAGE IS CONSISTENT WITH NORMAL WEAR AND TEAR AND IT HAS BEEN CONCLUDED THAT THIS IS THE MOST LIKELY CAUSE OF THE STEM PUNCH BEING DIFFICULT TO REMOVE FROM THE STEM. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    DURING SURGERY, THE METAFIX STRAIGHT STEM PUNCH BECAME STUCK IN SHOULDER OF THE DEFINITIVE STEM. THE INSTRUMENT WAS REMOVED FROM THE STEM USING A MALLET WHICH DISLODGED THE STEM SLIGHTLY. THE SURGEON REMOVED THE STEM FROM THE FEMORAL CANAL RE-BROACHED AND A LARGER STEM IMPLANTED.

    Description of Event or Problem · 0

    DURING SURGERY, THE METAFIX STRAIGHT STEM PUNCH BECAME STUCK IN SHOULDER OF THE DEFINITIVE STEM. THE INSTRUMENT WAS REMOVED FROM THE STEM USING A MALLET WHICH DISLODGED THE STEM SLIGHTLY. THE SURGEON REMOVED THE STEM FROM THE FEMORAL CANAL RE-BROACHED AND A LARGER STEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223383 METAFIX STRAIGHT STEM PUNCH JDI CORIN LTD 340.362 352748-05

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown METAFIX COLLARED STEM: 579.2102, 541859| METAFIX COLLARED STEM: 579.2102, 541859