BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 4287957 · Received December 1, 2014

    Report

    Report Number
    2530088-2014-10406
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED THE DEVICE HISTORY RECORD (DHR) REVIEW REPORTED: NEMCOMED (NOW OWNED BY AVALIGN TECHNOLOGIES ¿ NEMCOMED) MANUFACTURED THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS, P/N 357.369, AND LOT #5571933 ON PO #(B)(4) FOR (B)(4) PIECES PROCESSED ON BRANDYWINE WORK ORDER #(B)(4)ON (B)(4) 2008. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE, DATED (B)(4) 2008, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET #(B)(4). THE PARTS WERE RELEASED TO THE WAREHOUSE ON MARCH (B)(4) 2008. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS WAS MADE TO THE SYNTHES DRAWING P/N 357.369, REVISION ¿A¿, RELEASED ON (B)(4) 2001. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: THE RETURNED BLADE GUIDE SLEEVE WAS RECEIVED INTACT. THE SURFACES THAT INTERACT WITH THE MATING COMPONENTS ARE WORN FROM TYPICAL USE. THE RETURNED BLADE GUIDE SLEEVE WAS ASSEMBLED WITH THE RETURNED AIMING ARM AND BUTTRESS/COMPRESSION NUT. THE ASSEMBLY DID NOT HAVE ANY ISSUES WITH STICKING OR INTERFERENCE. THE MANUFACTURE DATE IS MARCH 17, 2008. THE COMPLAINED INSTRUMENTS WERE FUNCTIONALLY CHECKED USING THE FOLLOWING MATING COMPONENTS: 357.369 - BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS ¿ LOT# 5571933; 357.371 - BUTTRESS/COMPRESSION NUT FOR 357.369 - LOT# 5607664; 357.372 - HELICAL BLADE INSERTER - LOT# 5173134; 357.377 - HELICAL BLADE COUPLING SCREW - LOT# 4818089; 357.397 - CANNULATED CONNECTING SCREW F/TFN - LOT# 6606047; 456.308 - 11.0MM TI HELICAL BLADE 115MM - LOT# 6432748; 456.423 - 11MM/130 DEGREE TI CANNULATED TFN, 420MM/LEFT - LOT# 4374829. BENCH TESTING THE ASSEMBLY SHOWED NO INTERFERENCE BETWEEN THE PARTS WHEN THE HELICAL BLADE WAS INSERTED THROUGH THE NAIL. PRODUCT DRAWING FROM TIME OF MANUFACTURE WAS REVIEWED DURING THIS EVALUATION. NO DRAWING DISCREPANCIES WERE IDENTIFIED. THE ASSEMBLED INSTRUMENTS FUNCTIONED AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT IS UNCONFIRMED. 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 THE INSTRUMENTS WERE NOT WORKING PROPERLY. REPORTEDLY, THE HELICAL BLADE HITS THE NAIL AND WOULD ENGAGE. THE EVENT OCCURRED DURING AN IN-SERVICE NO PATIENT WAS INVOLVED THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774653 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 5571933

    Patients

    Seq Age Sex Outcome Treatment
    1