BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4287992 · Received December 1, 2014

    Report

    Report Number
    2530088-2014-10405
    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

    PRODUCT INVESTIGATION: THE RETURNED AIMING ARM WAS RECEIVED INTACT. THE SURFACES THAT INTERACT WITH THE MATING COMPONENTS ARE WORN FROM TYPICAL USE. THE RETURNED AIMING ARM WAS ASSEMBLED WITH THE RETURNED BLADE GUIDE SLEEVE AND BUTTRESS/COMPRESSION NUT. THE ASSEMBLY DID NOT HAVE ANY ISSUES WITH STICKING OR INTERFERENCE. THE MANUFACTURE DATE IS JUNE 28, 2006. 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 DRAWINGS FROM TIME OF MANUFACTURE WERE 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.

    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: BRANDYWINE INSTRUMENTS ASSEMBLY MANUFACTURED THE AIMING ARM FOR TROCHANTERIC FIXATION NAILS, P/N 357.366, LOT #5276083, FOR (B)(4) PIECES PROCESSED ON BRANDYWINES WORK ORDER #(B)(4) ON (B)(4) 2006. INITIALLY, THE PART CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #(B)(4), REVISION ¿B¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2006. THE AIMING ARM FOR TROCHANTERIC FIXATION NAILS WAS MADE TO THE SYNTHES DRAWING P/N 357.366, REVISION ¿B¿, RELEASED ON (B)(4) 2005. 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.

    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 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775305 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 5276083

    Patients

    Seq Age Sex Outcome Treatment
    1