BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 5105638 · Received September 25, 2015

    Report

    Report Number
    9615741-2015-00047
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 2, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K991477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 10/20/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: SPIN SCREW P/N 112014 LOT FBHD WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION HAS BEEN PERFORMED. THE ANOMALY IS CONFIRMED. SPIN SCREW IS BROKEN IN THREE PARTS, AT THE SNAP-OFF DIAMETER AND UNDER THE HEAD. IN CONCLUSION, SNAP-OFF DIAMETER AND SHAFT DIAMETER MEETS DESIGN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ANOMALIES DURING THE MANUFACTURING PERIOD OF 112014. THE MANUFACTURING LOT IS FBHD AND IT IS MANUFACTURED IN DECEMBER 2014. SNAP-OFF PART DIAMETER IS NOT CHECKED DURING THE INCOMING INSPECTION. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FOURTH INCIDENT FOR A BREAKAGE UNDER THE HEAD DURING IMPLANTATION (FOR THE PAST TWO YEARS) WHICH WAS REPORTED TO NEWDEAL. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4). A REVIEW OF NON-CONFORMANCE RECORDS FOR SPIN® SCREW 2.0MM IS PERFORMED. NO NONCONFORMANCE WAS FOUND FOR THE LAST TWO YEARS ON SNAP-OFF DIAMETERS. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE DOCUMENTARY REVIEW AND THE FAILURE ANALYSIS, THE ROOT CAUSE CANNOT BE DETERMINED. NO ANOMY WAS FOUND ON QUALITY RECORDS AND DURING FAILURE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BROKE DURING A PROCEDURE. DURING FOOT SURGERY, WHEN THE SURGEON WAS SCREWING THE SPIN SCREW INTO THE PATIENT'S BONE BY A HAND SCREW DRIVER, THE SPIN SCREW BROKE OFF FROM THE HEAD PART. ADDITIONAL INFORMATION RECEIVED INDICATED THE PROCEDURE PERFORMED FOR THIS EVENT WAS, "HALLUX VALGUS, NO RHEUMATISM." THE PROCEDURE WAS FINISHED BY TAKING OUT THE BROKEN SCREW WITH A NEEDLE-NOSE PLIERS AND FINISHING THE SURGERY WITH "DOUBLE LOOP SLIDING KNOT." IT WAS REPORTED, "... THERE WAS NO SERIOUS DAMAGE ON THE PATIENT SO FAR, BUT THERE IS POSSIBILITY OF NON-ARTICULAR DISEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636311 SPIN SCREW DIAM. 2MM LG 14MM SPIN HWC NEWDEAL SAS FBHD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR