BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM WIRE GUIDE FOR 3.7MM CANNULATED LOCKING SCREWS

    MDR report key: 2900065 · Received January 7, 2013

    Report

    Report Number
    3003506883-2013-00024
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 1.6MM WIRE GUIDES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE NONCONFORMANCE NOTED. NONCONFORMANCE NCR US1020412 WAS WRITTEN TO ADDRESS THE FINDING THAT THE INSIDE DIAMETER OF THE GUIDE WAS UNDERSIZED. THE LOT WAS INSPECTED 100 PERCENT AND ALL NONCONFORMING PIECES WERE REMOVED FROM THE LOT AND SCRAPPED, TOTAL OF 5 PIECES. THE REMAINDER OF THE LOT WAS INSPECTED AGAIN AT A SUBSEQUENT FINAL INSPECTION AND NO FURTHER NONCONFORMITIES WERE NOTED. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED ON THE RETURNED DEVICES AND THE REPORT INDICATES THE FOUR RETURNED GUIDES ARE MANUFACTURED FROM 17-4PH SS WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE WIRE GUIDES. THREE OF THE FOUR WIRE GUIDES SHOW DAMAGE TO A PORTION OF THE THREAD FORM. ON TWO WIRE GUIDES, THE CREST OF ONE ROTATION OF THREAD LOCATED MID-THREAD IS DEFORMED (BENT TO ONE DIRECTION) THEREBY DISTORTING THE THREAD PITCH. THE DEFORMATION IS INDICATIVE OF AN OFF AXIS FORCE APPLIED TO THE WIRE GUIDE WHILE NOT FULLY SEATED IN A MATING THREAD. ONE OF THE WIRE GUIDES SHOWS DAMAGE TO A PORTION OF THE THREAD FORM AT THE DISTAL TIP. THE CREST OF ONE ROTATION OF THE DISTAL MOST THREAD ROTATION IS DEFORMED (BENT TO ONE DIRECTION) THEREBY DISTORTING THE THREAD PITCH. THE DEFORMATION IS INDICATIVE OF AN OFF AXIS FORCE APPLIED TO THE WIRE GUIDE WHILE NOT FULLY SEATED IN A MATING THREAD. ONE WIRE GUIDE SHOWS NO DAMAGE TO THE THREAD. THREE OF THE DRILL GUIDES WERE MANUFACTURED ON JULY 16 2009 AND ARE OVER 3 YEARS OLD. AND ONE DRILL GUIDE WAS MANUFACTURED ON OCTOBER 8, 2010 AND IS OVER 2 YEARS OLD. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    SURGEON EXPERIENCED DIFFICULTY WITH DEVICES DURING A TIBIA PLATEAU FRACTURE PROCEDURE. A TOTAL A FOUR WIRE GUIDES WERE USED IN THE PROCEDURE AND REPORTED AS NOT ALIGNING PROPERLY WITH THE PLATE. THE ANGLES OF ALL 4 SCREWS WERE ANGLING UPWARD INSTEAD OF STRAIGHT ACROSS. THE ANGLES WERE CLOSE ENOUGH TO THE PROPER ANGLE THAT SURGEON DECIDED TO LOCK THE SCREWS AND COMPLETE THE PROCEDURE. SURGEON PLANNED TO IMPLANT 6 SCREWS IN THE PLATE, HOWEVER, ONLY 4 SCREWS WERE IMPLANTED. THIS IS # 7 OF 9 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7918 1.6MM WIRE GUIDE FOR 3.7MM CANNULATED LOCKING SCREWS 1.6MM WIRE GUIDE FZX SYNTHES ELMIRA 6175615

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR WIRE GUIDES, PLATE, SCREWS