BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 4777694 · Received May 18, 2015

    Report

    Report Number
    3003506883-2015-10081
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT WEIGHT WAS REPORTED AS APPROXIMATELY (B)(6) POUNDS. IT WAS REPORTED THAT THE SURGICAL PROCEDURE BEGAN ON (B)(6) 2015 AND WAS COMPLETED ON (B)(6) 2015. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: THE FOLLOWING SEVEN DEVICES FROM THE TROCHANTERIC FIXATION SET WERE RECEIVED IN GOOD CONDITION: PART 357.418 LOT 3024060; PART 357.419 LOT IS10174; PART 357.366 LOT 7862451; PART 357.369 LOT 4305616; PART 357.371 LOT 4405598; PART 456.304 LOT 7349398; PART 456.420 LOT 4865503. THE DEVICES HAD MINOR SCRATCHES AND WEAR CONSISTENT WITH REGULAR USE, BUT WERE IN OVERALL GOD CONDITION. THE RETURNED DEVICES WERE ASSEMBLED WITH KNOWN CONFORMING PARTS AVAILABLE AT THE CHU (PART 357.372 LOT 5675337 AND PART 357.377 LOT 4818089) AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE HELICAL BLADE WAS ABLE TO BE INSERTED AND NO ISSUES WERE ENCOUNTERED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. IT IS UNKNOWN WHAT CAUSED THE COMPLAINT CONDITION, BUT IT IS POSSIBLE TO SOFT TISSUE DISTRACTION FORCES PLAYED A ROLE IN CAUSING THE ISSUE. THIS COMPLAINT IS UNCONFIRMED. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE. 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 AN INTRAMEDULLARY TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE WITH CABLE WAS PERFORMED ON (B)(6) 2015 TO TREAT A SUB TROCHANTERIC FRACTURE OF THE RIGHT FEMUR THE SURGEON EXPERIENCED DIFFICULTY TRYING IN INSERT THE HELICAL BLADE THROUGH THE NAIL. THE HELICAL BLADE REPEATEDLY GOT JAMMED. THE SURGEON THEN REMOVED THE NAIL, CHECKED THE CONNECTIONS AND REREAMED THE FEMUR AND FEMORAL NECK. THE SURGEON THEN REINSERTED THE SAME NAIL. THERE WAS NO VISIBLE DAMAGE NOTED TO THE NAIL OR HELICAL BLADE. THE SAME BLADE WAS TRIED AGAIN UNSUCCESSFULLY. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH THE SAME INSTRUMENTATION USING A LAG SCREW INSTEAD OF THE HELICAL BLADE WITHOUT DIFFICULTY OR PATIENT HARM. THE REPORTED ISSUE RESULTED IN A 30 MINUTE SURGICAL DELAY. AFTER THE PROCEDURE THE SAME INSTRUMENTATION WAS USED TO SIMULATE A TFN PROCEDURE WITH A NEW HELICAL BLADE AND NAIL AND THE HELICAL BLADE DID NOT ADVANCE SMOOTHLY THROUGH THE NAIL. THIS REPORT ADDRESSES THE HELICAL BLADE THAT WAS TESTED AFTER THE PROCEDURE. THIS REPORT IS 9 OF 9 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322463 11.0MM TI HELICAL BLADE 95MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7349398

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR