BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER TORX T7

    MDR report key: 6104903 · Received November 15, 2016

    Report

    Report Number
    9615741-2016-00060
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    NEWDEAL SAS
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 4NOV2016. THE INVESTIGATION INCLUDED: METHOD: REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: DHR UNABLE TO BE REVIEWED AS LOT NUMBER WAS UNAVAILABLE. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE SECOND INCIDENT REPORTED TO NEWDEAL ABOUT A BREAKAGE OF A SURFIX® SYSTEM HEXALOBULAR SIZE 7 SCREWDRIVER DURING REMOVAL FOR THE PAST TWO YEARS. SCREWDRIVER TORX T7 ARE USED TO INSERT OR REMOVE SURFIX® FIXED ANGLE LOCKING SYSTEM AND SURFIX® ALPHA VARIABLE ANGLE LOCKING SYSTEM OF 2.7MM OR 3.0MM DIAMETER SCREWS AND LOCK-SCREWS. DURING THE SAME TIME PERIOD, (B)(4) PARTS WERE SOLD. PER CONSEQUENCE, THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS (B)(4) PERCENT. CONCLUSION: THE ROOT CAUSE CANNOT BE DETERMINED AS THE PRODUCT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 02/21/2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: DHR FOR LOT F6L9 AND FCMN REVIEWED AND NO ANOMALIES ASSOCIATED WITH THIS COMPLAINT WERE OBSERVED. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE SECOND INCIDENT REPORTED TO NEWDEAL ABOUT A BREAKAGE OF A SURFIX® SYSTEM HEXALOBULAR SIZE 7 SCREWDRIVER DURING REMOVAL FOR THE PAST TWO YEARS. SCREWDRIVER TORX T7 ARE USED TO INSERT OR REMOVE SURFIX® FIXED ANGLE LOCKING SYSTEM AND SURFIX® ALPHA VARIABLE ANGLE LOCKING SYSTEM OF 2.7MM OR 3.0MM DIAMETER SCREWS AND LOCK-SCREWS. DURING THE SAME TIME PERIOD, (B)(4) PARTS WERE SOLD. PER CONSEQUENCE, THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS 0.011 PERCENT. THIS IS THE FIRST INCIDENT FOR LOT F6L9 MANUFACTURED ON APRIL 2013 AND (B)(4) PARTS WERE RELEASED. THE LOT FAILURE IS 3.7%. THIS IS THE FIRST INCIDENT FOR LOT FCMN MANUFACTURED ON JUNE 2015 AND (B)(4) PARTS WERE RELEASED. THE LOT FAILURE IS 2.63%. A REVIEW OF NON-CONFORMANCE RECORDS AND DEVIATION FILES IS PERFORMED FOR THE LAST TWO YEARS. NO RESULTS FOUND ABOUT A BREAKAGE OF SCREWDRIVER TORX T7. CONCLUSION: THE SCREWDRIVER TORX T7 IS USED TO REMOVE THE SCREWS FROM THE PLATE, THE EFFORT APPLIED TO REMOVE THE BLOCKED COUNTER-SCREW CAN EXPLAIN THE BREAKAGE OF THE SCREWDRIVER TORX T7 AT THE PART WHICH IS IN CONTACT WITH THE LOCK SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED 2 SCREWDRIVERS BROKE DURING REMOVAL OF BLOCKED COUNTER SCREW. IT WAS REPORTED THE ONLY CONSEQUENCE FOR THE PATIENT IS ONLY THE INCREASE OF SURGERY TIME. ALTHOUGH THE DEVICE WAS IN CONTACT WITH THE PATIENT, IT WAS REPORTED THERE WAS NO PATIENT INJURY. IT WAS REPORTED THE EVENT LED TO A SIGNIFICANT INCREASE IN SURGERY TIME BUT THE LENGTH OF TIME WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752597 SCREWDRIVER TORX T7 N/A HXX NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1