BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 3890012 · Received June 24, 2014

    Report

    Report Number
    2530088-2014-10169
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HST
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE BY THE COMPLAINT HANDLING UNIT REPORTED THE BUTTRESS/ COMPRESSION NUT SHOWS WEAR AND TEAR ALLOVER ON THE SURFACE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE RECEIVED INFORMATION THE INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OR REPRODUCE THE COMPLAINED ISSUE. THE DEVICE WORKS ACCORDING TO INTENDED DESIGN WHEN MOUNTED ON THE COUNTER PART (357.369). THE WEAR AND TEAR SIGNS CAN BE REFERRED TO AS NORMAL USE OF THE DEVICE. THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE WITHIN SPECIFICATIONS, THEREFORE THE INSTRUMENT WORKED CORRECTLY WHEN DISTRIBUTED. NO FURTHER INVESTIGATION NEEDED BECAUSE NO PRODUCT FAULT COULD BE DETECTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: BUTTRESS/COMPRESSION NUT (357.371 LOT 5691245) WITH A GUIDE SLEEVE (357.369 LOT 4657255). MINOR WEAR EXISTS ON BOTH DEVICES CONSISTENT WITH TYPICAL USE. THE THREADS ON THE GUIDE SLEEVE ARE DENTED IN MULTIPLE PLACES. PER THE TECHNIQUE GUIDE: THE BUTTRESS/COMPRESSION NUT (357.371 LOT 5691245) IS A COMPONENT OF THE TROCHANTERIC FIXATION NAIL (TFN) SYSTEM AND IS USED TO AID THE ALIGNMENT AND INSERTION OF THE HELICAL BLADE FOR PROXIMAL LOCKING. AFTER THE NAIL IS INSERTED INTO THE FEMUR, AN AIMING ARM IS ATTACHED TO THE INSERTION HANDLE AND A BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE ASSEMBLY ARE INSERTED THROUGH THE AIMING ARM. THE NUT IS ROTATED TO ADVANCE THE BLADE GUIDE SLEEVE TO THE BONE. WITH THE GUIDE SLEEVE IN PLACE, A GUIDE WIRE CAN BE INSERTED, A HOLE DRILLED AND THE HELICAL BLADE CAN BE INSERTED AND LOCKED INTO THE NAIL. THE TOP LEVEL DRAWING FOR THE BUTTRESS/COMPRESSION NUT USED AT THE TIME OF MANUFACTURE WAS REVIEWED AND FOUND TO BE SUITABLE FOR ITS INTENDED USE. THE BUTTRESS/COMPRESSION NUT WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE RETURNED COMPONENTS WERE ASSEMBLED TO COMPLETE THE INSERTION CONSTRUCT IN AN ATTEMPT TO REPLICATE THE COMPLAINT CONDITION. THE MATING COMPONENTS USED WERE: A BLADE GUIDE SLEEVE (357.369 LOT 4657255) AND A BUTTRESS/COMPRESSION NUT (357.371 LOT 5691245) AND 130 DEGREE AIMING ARM (357.366 LOT 4799867). THE BLADE GUIDE SLEEVE WITH COMPRESSION NUT WAS INSERTED INTO THE RETURNED AIMING ARM AND THE LOCKING MECHANISM ON THE AIMING ARM WAS ABLE TO RETAIN AND RELEASE THE COMPRESSION NUT ON EACH ATTEMPT. THERE WAS A SIGNIFICANT AMOUNT OF ROTATIONAL PLAY IN THE SLEEVE/NUT ASSEMBLY WHEN LOCKED INTO THE AIMING ARM. AS SUCH, THE COMPLAINT CONDITION OF LOOSE IS CONFIRMED. THE BUTTRESS/COMPRESSION NUT WAS RECEIVED WITH AN AIMING ARM AND A BLADE GUIDE SLEEVE UNDER THE COMPLAINT CONDITION ¿LOOSE¿. ALL THREE RETURNED COMPONENTS WERE ASSEMBLED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED, AS SUCH THE COMPLAINT IS CONFIRMED. THE AIMING ARM IS 10 YEARS OLD, AND THE COMPLAINT CONDITION IS LIKELY THE RESULT OF TYPICAL WEAR AND TEAR ON THE DEVICE OVER THE COURSE OF ITS LIFE. SINCE THE COMPLAINT CONDITION IS LIKELY THE RESULT OF WEAR AND NOT A DESIGN DEFECT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INVENTORY CHECK PRIOR TO SURGERY IT WAS NOTED THE INSTRUMENTS WERE NOT WORKING CORRECTLY. NO PATIENT OR PROCEDURE INVOLVEMENT. THE INSTRUMENT AND ISSUES REPORTED ARE AS FOLLOWS: TORQUE LIMITING ATTACHMENT HAD COME UNSCREWED AND THE SPRING WAS MISSING. AIMING ARM IS WORN AND HOOKS INTO ANOTHER PIECE; IT IS LOOSE. BLADE GUIDE SLEEVE'S THREADS ARE SMASHED/DEFORMED, AND IT IS LOOSE. BUTTRESS/COMPRESSION NUT IS WORN AND HOOKS INTO ANOTHER PIECE; IT IS LOOSE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369126 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED HST SYNTHES BRANDYWINE 5691245

    Patients

    Seq Age Sex Outcome Treatment
    1