BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 5356729 · Received January 11, 2016

    Report

    Report Number
    1719045-2016-10034
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCOMITANT DEVICES ¿ THE HELICAL BLADE INSERTER WAS RE-REVIEWED BASED UPON NEW INFORMATION. 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. 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

    PATIENT ID/INITIAL AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    PART 357.369, LOT 6984106: RELEASE TO WAREHOUSE DATE: SEPTEMBER 27, 2012. SUPPLIER- (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS, PART NUMBER 357.369, LOT NUMBER 6984106). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE HELICAL BLADE BECOMING STUCK DURING SURGERY. THIS CONDITION IS UNCONFIRMED; THE HELICAL BLADE INSERTER FUNCTIONS AS INTENDED AND PASSES THROUGH THE BLADE GUIDE SLEEVE WITHOUT DIFFICULTY. A VISUAL INSPECTION, DIMENSIONAL INSPECTION, DRAWING REVIEW, AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED WITH THE 357.369 BLADE GUIDE SLEEVE. THE CAUSE OF THIS COMPLAINT CONDITION CANNOT BE DETERMINED. THE COMPLAINT CONDITION CANNOT BE REPLICATED. 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

    UPDATE: THE INVESTIGATION CONDUCTED ON THE RETURNED DEVICES WAS COMPLETED ON (B)(4) 2016. IT WAS DURING THIS INVESTIGATION THAT THE HELICAL BLADE INSERTER, WHICH WAS ORIGINALLY DOCUMENTED TO BE A CONCOMITANT DEVICE, WAS ACTUALLY BROKEN AT AN UNKNOWN TIME DURING THE PROCEDURE. THEREFORE, THE DEVICE IS BEING ADDED TO THE COMPLAINT. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING A TROCHANTERIC FIXATION NAIL (TFN), THE BLADE BECAME STUCK AND COULD NOT BE ADVANCED OR REMOVED. A SLAP HAMMER AND AN EXTRACTION DEVICE WERE USED TO REMOVE THE TROCHANTERIC FIXATION NAIL CAUSING A TWENTY (20) MINUTE SURGICAL DELAY. A SECOND TFN NAIL SET WAS USED TO COMPLETE THE SURGERY WITHOUT ANY ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO KNOWN IMPACT TO THE PATIENT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16968 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES MONUMENT 6984106

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR