BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 5093146 · Received September 21, 2015

    Report

    Report Number
    2530088-2015-10590
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    September 8, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ DHR REVIEW FOR PART#357.369 LOT#4964345. RELEASE TO WAREHOUSE DATE: NOV 17, 2005. MANUFACTURED AT SYNTHES (B)(4). MATERIAL RECORD REPORT WAS WRITTEN FOR VISUAL NONCONFORMANCES (SCRATCHES AROUND O.D.). PARTS WERE 100% REINSPECTED AND DISPOSITIONED AS CONFORMS TO SPECIFICATIONS. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE COMPLAINT DESCRIBES BINDING BETWEEN THREADED PORTION OF THIS DEVICE WITH MATING DEVICE'S THREAD AND THE SCRATCHES IDENTIFIED ON THE MRR WERE ON THE NON-THREADED AREAS. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PRODUCT INVESTIGATION SUMMARY: ONE BUTTRESS/COMPRESSION NUT (PART 357.371 / LOT 5013309) AND ONE BLADE GUIDE SLEEVE (PART 357.369 / LOT 4964345) WERE RECEIVED WITH THE COMPLAINT CATEGORIES: ¿DEVICE INTERACTION: STICKS/JAMS/STUCK¿ AND ¿DOES NOT/WILL NOT FUNCTION: CROSS THREADED,¿ RESPECTIVELY. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED AS THE BUTTRESS/COMPRESSION NUT WAS UNABLE TO BE FULLY UNTHREADED FROM THE BLADE GUIDE SLEEVE DUE TO THREAD DAMAGE ON THE SLEEVE APPROXIMATELY 1/3 OF THE WAY DOWN FROM THE PROXIMAL END OF THE INSTRUMENT. THE BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE ARE COMPONENTS OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE DEVICES ARE SPECIFICALLY FOR THE INSERTION OF THE HEAD ELEMENT INTO THE NAIL. INFORMATION IS PROVIDED PER TECHNIQUE GUIDES. THE RETURNED DEVICES WERE RECEIVED WITH SIGNIFICANT SURFACE SCRATCHES, WEAR, AND DENTS. THERE IS DEFORMATION AND SCRATCHES ON THE KNURLED SURFACE OF THE BUTTRESS COMPRESSION NUT. ADDITIONALLY, THE DISTAL EDGE OF THE BUTTRESS COMPRESSION NUT IS ROLLED OVER AND THERE SCRATCHES AND DENTS ON THE THREADS OF THE BLADE GUIDE SLEEVE. WHEN TESTED FUNCTIONALLY, THE BUTTRESS/COMPRESSION NUT COULD NOT BE ADVANCED OVER THE ENTIRE THREADED LENGTH OF THE BLADE GUIDE SLEEVE AS IT WOULD BIND APPROXIMATELY 1/3 OF THE WAY DOWN FROM THE PROXIMAL END OF THE INSTRUMENT. THUS, THE COMPLAINT CONDITION IS CONFIRMED, CONSISTENT WITH THE REPORTED CONDITION AND WAS ABLE TO BE REPLICATED. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION FOR THE BUTTRESS/COMPRESSION NUT AND THE BLADE GUIDE SLEEVE WAS PERFORMED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. SINCE THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE DAMAGE ARE UNKNOWN THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. HOWEVER, IT IS MOST PROBABLE THAT ACCUMULATED WEAR FROM ROUGH HANDLING AND EXCESSIVE FORCE DURING SURGERY AND/OR STERILE PROCESSING RESULTED IN THIS CONDITION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 A PATIENT HAD WEEK OF (B)(6) 2015 DUE TO A HIP FRACTURE. THE TROCHANTERIC FIXATION NAIL SYSTEM WAS UTILIZED. DURING SURGERY, THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS (THREADED TROCAR) (357.369; LOT #: 4964345) AND THE BUTTRESS/COMPRESSION NUT (357.371; LOT #: 5013304) BECAME CROSS THREADED AND BOUND UP. THE SURGEON WAS UNABLE TO ADVANCE THE NUT ON THE TROCAR. THE SURGEON WAS UNABLE TO ADVANCE THE NUT ON THE TROCAR AND THEREFORE, THE PARTS WERE UNABLE TO BE SEPARATED AFTER THE SURGERY. THIS DELAYED THE PROCEDURE BY APPROXIMATELY FIVE (5) TO TEN (10) MINUTES AND THE SURGEON SUCCESSFULLY FINISHED THE PROCEDURE WITHOUT ANY SURGICAL/MEDICAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT STATUS/OUTCOME IS UNKNOWN. NO FURTHER SURGERY OR SPECIAL FOLLOW UP IS EXPECTED TO BE REQUIRED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622151 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4964345

    Patients

    Seq Age Sex Outcome Treatment
    1