BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 4180970 · Received October 17, 2014

    Report

    Report Number
    9612488-2014-10447
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE ARTICLES ARE BLOCKED TOGETHER. THE BLOCKED DEVICES WERE REMOVED TOGETHER WITH THE RESPONSIBLE PRODUCT MANAGER, THE MANAGER WAS ABLE TO SEPARATE THE BLADE FROM THE IMPACTOR. FUNCTIONAL TESTING SHOWED THAT ALL DEVICES ARE FUNCTIONAL AS REQUIRED. BASED ON THE PROVIDED COMPLAINT DESCRIPTION THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF EITHER WRONG DIRECTION OF ROTATION OF THE LEFT-HAND THREADED MECHANISM OR THE USE OF THE KEY 356.823 CAUSED THE BLOCKING OF THE DEVICES. IN THIS RELATION WE WOULD LIKE TO POINT OUT THIS KEY SHOULD BE ONLY USED FOR THE REMOVAL OF THE BLADE. THE IMPACTOR 356.823 IS AN OLD VERSION AND SHOULD BE REPLACED WITH THE ARTICLE 03.010.410 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 PART AND LOT NUMBER OF THE RETURNED DEVICES DO NOT MATCH THE INFORMATION REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. G5 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE SURGEON INTRODUCED THE IMPACTOR WITH THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE ON IT FOR PLACEMENT HOWEVER WHEN HE TRIED TO REMOVE IT THE HARDWARE JAMMED. THE SURGEON REMOVED THE IMPACTOR WITH THE DRILL SLEEVE AND BLADE ATTACHED AS ONE PIECE. THIS EVENT RESULTED IN A TWO HOUR DELAY IN SURGERY. PATIENT OUTCOME WAS REPORTED TO BE ¿OKAY¿. THE PROBLEM WAS RESOLVED BY USING A PLIER WRENCH, STRIKING FORWARD AND BACK UNTIL THE BLADE RELEASED, THE SURGEON WAS THEN ABLE TO PLACE ANOTHER WITH THE INSTRUMENTAL EXTRACTION THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663004 IMPACTOR F/PFNA BLADE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. HWA SYNTHES BETTLACH 2527522

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention