BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3839569 · Received May 29, 2014

    Report

    Report Number
    2530088-2014-10146
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONE 130 DEGREE AIMING ARM, FOR TROCHANTERIC FIXATION NAILS (PART 357.366), ONE BLADE GUIDE SLEEVE (PART 357.369), ONE BUTTRESS/COMPRESSION NUT (PART 357.371), ONE HELICAL BLADE INSERTER (PART 357.372), ONE HELICAL BLADE COUPLING SCREW (PART 357.377), AND ONE 11.0MM/3.2MM WIRE GUIDE (PART NUMBER 357.381), WERE RECEIVED. ONE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART NUMBER 356.315S) WAS NOT RECEIVED. THE RETURNED COUPLING SCREW, LOT 5638309, WAS MANUFACTURED MARCH, 2008. THE RETURNED WIRE GUIDE, LOT 5685303, WAS MANUFACTURED MARCH, 2008. THE RETURNED BUTTRESS/COMPRESSION NUT, LOT 4565977, WAS MANUFACTURED JULY, 2003. THE RETURNED HELICAL BLADE INSERTER, LOT 5780353, WAS MANUFACTURED MAY, 2008. THE RETURNED BLADE GUIDE SLEEVE, LOT 4545112, WAS MANUFACTURED JANUARY, 2004. THE RETURNED AIMING ARM, LOT 4773559, WAS MANUFACTURED MAY, 2004. THE NAIL, LOT 7123711, WAS MANUFACTURED DECEMBER, 2012 AND WAS NOT RECEIVED AS IT REMAINS IMPLANTED IN THE PATIENT. THE RETURNED DEVICES COLLECTIVELY SHOW DAMAGE FROM HAMMERING. THE RETURNED COUPLING SCREW WAS RECEIVED WITH THE PROXIMAL END HEAVILY HAMMERED AND THE HEX DRIVE WORN. THIS IS CONSISTENT WITH THE WEAR FROM USE AS THE PROXIMAL END OF THE COUPLING SCREW IS THE ONE LOCATION DESIGNED TO BE HAMMERED DURING HELICAL BLADE INSERTION. THE RETURNED AIMING ARM, WIRE GUIDE, BUTTRESS/COMPRESSION NUT, HELICAL BLADE INSERTER, AND BLADE GUIDE SLEEVE WERE RECEIVED INTACT AND FUNCTIONING BUT SHOWED HAMMER DENTS AND SURFACE SCRATCHES. THIS CONDITION IS CONSISTENT WITH THE EXPECTED DAMAGE FROM FORCEFUL MISALIGNMENT. THE FLATS ON THE HELICAL BLADE INSERTER GUIDE PINS MATCHES THE DENTS ON THE BLADE GUIDE SLEEVE WHICH IS EVIDENCE OF MISALIGNMENT AND THERE ARE CLEAR HAMMER MARKS OVER THE SURFACE OF EACH DEVICE. TO REPLICATE THE COMPLAINT CONDITION, A TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART 456.305, LOT 4374829), INSERTION HANDLE (PART 357.411, LOT 4522808), CANNULATED CONNECTING SCREW (PART 357.397, LOT 6606047) AND HELICAL BLADE (PART 456.305) WERE USED WITH THE RETURNED DEVICES. THE CONSTRUCT WAS ASSEMBLED TO THESE KNOWN GOOD PARTS AND AT NO TIME DID THE CONSTRUCT FAIL TO PROPERLY ALIGN. THUS, THE COMPLAINT CONDITION IS UNCONFIRMED. THESE DEVICES ARE NOT SPECIFIED TO BE HAMMERED SO IT IS LIKELY THAT HAMMERING LOOSENED THE CONNECTING SCREW WHICH ALLOWED THE DEVICES TO BE FORCED OUT OF POSITION AND SOFT TISSUE TO HOLD IT OUT OF ALIGNMENT. THE TECHNIQUE GUIDE RECOMMENDS THAT THE USER CONFIRM THAT THE NAIL IS TIGHTLY CONNECTED TO THE INSERTION HANDLE, ESPECIALLY AFTER HAMMERING AND SPECIFIES THE PROPER TECHNIQUE AND DEVICE MAINTENANCE. THEREFORE, THE METHOD OF USE WAS LIKELY THE CAUSE OF ANY MISALIGNMENT. A REVIEW OF THE CURRENT DESIGN DRAWINGS WAS PERFORMED. THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE AND THE DESIGN HISTORIES DID NOT IMPACT THE COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY OF THE RETURNED DEVICES. IN CONCLUSION, THE COMPLAINT CONDITION IS UNCONFIRMED BECAUSE THE COMPLAINT CONDITION COULD NOT BE REPLICATED AND THE TROCHANTERIC FIXATION NAIL WAS NOT RETURNED. WITHOUT ADDITIONAL INFORMATION, THE ROOT CAUSE IS INDETERMINATE. 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. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF A TROCHANTERIC FIXATION NAIL SYSTEM DURING SURGERY. THE SURGEON WAS REPAIRING AN INTERTROCHANTERIC FRACTURE AND WHILE AT THE START OF THE PROCEDURE WHERE THE HELICAL BLADE GOES INTO THE GUIDE WIRE, THE SURGEON HAD TROUBLE GETTING THE BLADE TO PASS THROUGH THE NAIL. IT WAS REPORTED THAT THE SURGEON EVENTUALLY WAS ABLE TO GET THE BLADE TO PASS BUT FEELS THAT THE LOCKING SCREW INSIDE THE NAIL MALFUNCTIONED BECAUSE THE LOCKING DRIVE AND LOCKING PRONG WAS DOWN INSTEAD OF UP AS IT WAS SUPPOSED TO BE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT ADVERSE EVENT REPORTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315333 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5638309

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR