BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 5344300 · Received January 5, 2016

    Report

    Report Number
    2520274-2016-10042
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: THE COMPLAINT CONDITION FOR THE HELICAL BLADE COUPLING SCREW (PART 357.377 / LOT 7052432), HELICAL BLADE INSERTER (PART 357.372 / LOT 4700437), AIMING ARM (PART 357.366 / LOT 4377504), BLADE GUIDE SLEEVE (PART 357.369 / LOT 5103086), 11.0MM/3.2MM WIRE GUIDE (PART 357.381 / LOT 5237013), AND 3.2MM TROCAR (PART 357.383 / LOT 4588827) WAS LIKELY CAUSED BY PRESSURE FROM SOFT TISSUE AND POSSIBLY INSUFFICIENT FASTENING OF THE AIMING DEVICE CONNECTIONS. HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE DEVICES ARE ALL INSTRUMENTS ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE CONTRIBUTED TO THE HELICAL BLADE BEING UNABLE TO ADVANCE THROUGH THE NAIL. THIS CONDITION IS UNCONFIRMED; WHEN THE COMPLAINED PARTS WERE ASSEMBLED WITH A SAMPLE TROCHANTERIC FIXATION NAIL, HELICAL BLADE, BUTTRESS/COMPRESSION NUT, INSERTION HANDLE, AND CANNULATED CONNECTING SCREW, THE HELICAL BLADE TARGETS THE PROXIMAL LOCKING HOLE OF THE NAIL AS DESIGNED WITHOUT DIFFICULTY. IT IS LIKELY THAT PRESSURE FROM SOFT TISSUE OR POSSIBLY INSUFFICIENT FASTENING OF THE AIMING DEVICE CONNECTIONS HAS LED TO THIS COMPLAINT CONDITION. THE COUPLING SCREW WAS MANUFACTURED IN NOVEMBER, 2012 AND IS OVER THREE YEARS OLD. THE INSERTER WAS MANUFACTURED IN JANUARY, 2004 AND IS TWELVE YEARS OLD. THE AIMING ARM WAS MANUFACTURED IN JUNE, 2002 AND IS OVER THIRTEEN YEARS OLD. THE SLEEVE WAS MANUFACTURED IN JULY, 2006 AND IS OVER NINE YEARS OLD. THE WIRE GUIDE WAS MANUFACTURED IN JUNE, 2006 AND IS OVER NINE YEARS OLD. THE TROCAR WAS MANUFACTURED IN MAY, 2003 AND IS OVER TWELVE YEARS OLD. EACH OF THE RETURNED DEVICES IS IN FAIRLY WORN CONDITION AS APPROPRIATE FOR THEIR RESPECTIVE AGES. THE RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW - PART NUMBER: 357.366. LOT NUMBER: 4377504. RELEASE TO WAREHOUSE DATE: JUNE 5, 2002. MANUFACTURED BY SYNTHES (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE HELICAL BLADE KEPT HITTING THE NAIL DURING INSERTION AND IT DIDN'T PASS THROUGH ALL THE WAY. THERE WAS NO REPORT OF INSTRUMENT OR DEVICE BREAKAGE OR FRAGMENT GENERATION. THE SURGEON HAD TO USE COMPETITOR'S DEVICES FROM TO COMPLETE THE PROCEDURE. THERE WAS A 15 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE WAS COMPLETED THE SURGICAL STAFF AND THE SYNTHES SALES CONSULTANT TRIED TO RECONSTRUCT THE TROCHANTERIC FIXATION NAIL SYSTEM USING THE COMPLAINED IMPLANTS AND INSTRUMENTS AT THE BACK TABLE AND FOUND THAT THE HELICAL BLADE STILL KEPT HITTING THE NAIL AND THERE WAS AN APPARENT ALIGNMENT ISSUE. THIS REPORT IS 3 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4791 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4377504

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR