BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM LOCKING SCREWS

    MDR report key: 6566871 · Received May 15, 2017

    Report

    Report Number
    3008951116-2017-00005
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    November 18, 2016
    Report Date
    May 10, 2017
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HWC
    PMA / PMN Number
    K141784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO SOLUTIONS CARRIED OUT A COMPREHENSIVE INVESTIGATION INTO THE CIRCUMSTANCES THAT MAY HAVE LED TO THIS SITUATION. A SUMMARY OF THE FINDINGS AND THE CONCLUSION OF THE INVESTIGATION ARE ABRIDGED BELOW. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE SCREWS AND PLATES PASSED INSPECTION UPON COMPLETION OF MANUFACTURING IN ACCORDANCE TO THE APPROVED DESIGN. THE PRODUCTS WERE QUALITY INSPECTED AT ORTHO SOLUTIONS AND PASSED ALL DIMENSIONAL AND MATERIAL SPECIFICATION. THERE WERE NO NON-CONFORMITIES WITH THE PRODUCT IDENTIFIED WHICH COULD HAVE LED TO THIS COMPLAINT ISSUE. THE ULTOS PLATES AND SCREWS ARE ONE OF FIVE TOP MOST USED SYSTEMS DISTRIBUTED IN (B)(4). (B)(4). REVIEWING THE X-RAY IT WOULD APPEAR THAT THERE ARE DIFFERENCES BETWEEN THE RIGHT AND LEFT MTP FUSION PROCEDURES. THE RIGHT 1ST MTP HEAD APPEARS SHORTER THAN THAT OF THE LEFT FOOT AND REDUCTION OF THE OSTEOTOMY SITE DOES NOT APPEAR TO BE AS COMPLETE AS THAT ACHIEVED ON THE LEFT. SUCH DIFFERENCES MAY BE THE RESULT OF A NUMBER OF PRE-OPERATIVE OR PER-OPERATIVE FACTORS OR MAY ALSO BE SECONDARY TO SCREW FIXATION FAILURE AND DEVICE LOOSENING. WITH THE DATA AVAILABLE AT HAND IT WAS NOT POSSIBLE TO ASSESS IF THE SCREW FAILURE COMPROMISED THE REDUCTION OF THE OSTEOTOMY. IT IS ALSO NOT POSSIBLE TO DEDUCE FROM THE SINGLE X-RAY IF THIS SECONDARY TO THE METALWORK FAILURE. REVIEW OF THE PRODUCT HISTORY AND FAILURE RATE DOES NOT REQUIRE ANY CORRECTIVE ACTIONS TO BE TAKEN AGAINST THE SCREWS OR PLATES IN THE ULTOS SYSTEM AT THIS POINT. IF ANY FURTHER CLINICAL INFORMATION IS PROVIDED THE INVESTIGATION CAN BE REVIEWED AGAIN TO HELP IDENTIFY A CAUSE OF FAILURE THAT MAY BE INHERENT IN THE SCREWS THEMSELVES.

    Description of Event or Problem · 1

    SURGEON PERFORMED A BILATERAL MTP FUSION USING A 3.5 CANN SCREW ACROSS THE JOINT AND MTP PLATES ON BOTH SIDES. THE BONE SURFACES WERE PREPARED USING THE MTP REAMERS. THERE WERE NO COMPLICATIONS DURING SURGERY. THREE (3) MONTHS ROUTINE POST-OP X-RAY SHOWED THAT ON ONE SIDE 2 PROXIMAL SCREWS HAD BROKEN AND ON THE OTHER SIDE ONE SCREW HAD BROKEN. THE SURGEON WILL RE-XRAY THE PATIENT AT 6 MONTHS TO SEE IF BOTH SIDES HAVE FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349164 2.7MM LOCKING SCREWS SCREW HWC ORTHO SOLUTIONS UK LTD N/A 20316H15, 30216H15

    Patients

    Seq Age Sex Outcome Treatment
    1