BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER TORX T7

    MDR report key: 4934750 · Received July 21, 2015

    Report

    Report Number
    9615741-2015-00037
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K083154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 8/6/2015. THE INVESTIGATION INCLUDED: METHOD: -DHR, -REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. -VISUAL INSPECTION. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD IS DONE THE MANUFACTURING LOT IS FCMN AND IT HAS BEEN MANUFACTURED IN JUNE 2015. NO ANOMALY WAS FOUND, PARTICULARLY ABOUT TIP SPECIFICATIONS, RAW MATERIAL AND HEAT TREATMENT DURING THE MANUFACTURING PERIOD OF THE PRODUCT. IN CONCLUSION, TIP SPECIFICATIONS, RAW MATERIAL AND HEAT TREATMENT ARE CHECKED DURING INCOMING INSPECTION. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FOURTH INCIDENT REPORTED TO NEWDEAL ABOUT A BREAKAGE OF A SURFIX SYSTEM HEXALOBULAR SIZE 7 SCREWDRIVER DURING REMOVAL FOR THE PAST TWO YEARS. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4) PERCENT. A VISUAL INSPECTION WAS PERFORMED. A BREAKAGE HAS BEEN OBSERVED. THE HEXALOBULAR TIP IS BROKEN. NO MEASUREMENT INSPECTION WAS PERFORMED AS THE TIP IS TOO DAMAGED TO BE MEASURED. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS DURING THE INVESTIGATION, THE ROOT CAUSE IS AN OVERSTRESS IN TORSION APPLIED ON THE SCREWDRIVER TIP. THE INCIDENT IS CONFIRMED AS THE TIP TWISTED BEFORE THE BREAKAGE.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BROKE WHILE IN USE. THE TIP OF THE SCREWDRIVER BROKE IN THE LOCK-SCREW DURING UNSCREWING. PART OF THE DEVICE STAYED INSIDE THE PRINT OF THE SCREW, SO THE SCREWDRIVER COULD NOT FINISH THE REMOVAL. AT THE END THE PLATE WAS REMOVED AFTER THE SCREW BROKE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL: "THE PLATE WAS IMPLANTED 5 YEARS AGO. THE REMOVAL OF THE OSTEOTOMY MATERIAL WAS PERFORMED AS THE PATIENT FELT DISCOMFORT. THE FACT THAT THE MATERIAL HAS BEEN IMPLANTED FOR SEVERAL YEARS COULD PROBABLY EXPLAIN THE BLOCKING OF THE COUNTER-SCREW. A STRONGER TOOL THAN THE SCREWDRIVER COULD BE USEFUL FOR THIS CASE." CLARIFICATION OF THE EVENT WAS RECEIVED. THE SCREW AND THE PLATE REMAINED IMPLANTED DURING 5 YEARS. DURING THE REVISION SURGERY, THE TIP OF THE SCREWDRIVER BROKE. THE TIP NEVER STAYED "IMPLANTED" INTO THE PATIENT. IT WAS REPORTED THE EVENT LED TO AN INCREASE IN SURGERY TIME OF 60 MINUTES; HOWEVER, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473839 SCREWDRIVER TORX T7 HRS NEWDEAL SAS FCMN

    Patients

    Seq Age Sex Outcome Treatment
    1