BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 5385249 · Received January 22, 2016

    Report

    Report Number
    1719045-2016-10087
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 7, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS ARE MNM. AGE AND WEIGHT NOT PROVIDED BY REPORTER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW PART NUMBER: 357.369 LOT NUMBER: 7686175 RELEASE TO WAREHOUSE DATE: OCTOBER 9, 2014. MANUFACTURING SITE IS SYNTHES MONUMENT AND SUPPLIED BY (B)(4) NO NCRS 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. 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 INVESTIGATION SUMMARY - THE RETURNED 357.366 LOT NUMBER 8893472 AIMING ARM, 357.369 LOT NUMBER 7686175 BLADE GUIDE SLEEVE, AND 357.371 LOT NUMBER 7681977 BUTTRESS/COMPRESSION NUT SHOW SEVERAL MARKINGS AND OTHER SIGNS OF WEAR ALTHOUGH NOTHING THAT WOULD IMPAIR THEIR FUNCTION. THE DEVICES FUNCTION AS DESIGNED. 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. THE CAUSE OF THIS COMPLAINT CONDITION CANNOT BE DETERMINED. THE BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE ASSEMBLY WERE REPORTED TO BE POPPING OUT OF THE AIMING ARM DURING SURGERY. THIS COMPLAINT IS UNCONFIRMED. THE COMPLAINT CONDITION CANNOT BE REPLICATED. THE AIMING ARM RETAINS THE BUTTRESS/COMPRESSION NUT DESPITE THE APPLICATION OF A MODERATE AMOUNT OF FORCE TO THE ASSEMBLY. NO DESIGN ISSUE WAS FOUND DURING THE INVESTIGATION OF THESE DEVICES. 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 DURING A PROCEDURE TO REPAIR A RIGHT HIP FRACTURE, ON (B)(6) 2016, WHEN TRYING TO INSERT THE TROCHANTERIC FIXATION NAIL (TFN) BLADE, THE TFN BLADE SLEEVE/COMPRESSION NUT KEPT POPPING OUT OF THE 130 DEGREE AIMING ARM. THIS OCCURRED TWICE IN THE SAME PROCEDURE. EACH TIME THE NUT POPPED OUT, IT WAS PUT INTO PLACE AND THE PROCEDURE CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE PARTS WITH AN APPROXIMATE ONE MINUTE DELAY AND NO PATIENT HARM. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43926 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES MONUMENT 7686175

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR