BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L120 TAN

    MDR report key: 3830035 · Received May 23, 2014

    Report

    Report Number
    9612488-2014-10194
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: WEIGHT REPORTED AS (B)(6). ADDITIONAL PRODUCT CODE: HWC. THE ORIGINAL IMPLANT DATE WAS IN 2012. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE 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. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE; AS RECEIVED CONDITION OF DEVICE SCRATCHES OF THE REMOVAL ARE VISIBLE. NO OTHER VISUAL SIGNS OF DAMAGES WERE FOUND. THE REPORTED COMPLAINT SITUATION USING APPROPRIATE ALTERNATIVE DEVICES COULD NOT BE REPLICATED. IN A FUNCTIONAL TEST, THE LOCKING MECHANISM WORKED AS INTENDED. IT IS NOTED THAT DIFFICULTIES MAY ARISE DUE TO PATIENT AGE AND/OR GOOD BONE QUALITY. IF THE EXTRACTION OF THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE IS DIFFICULT, REMOVE THE LOCKING BOLT AND THE END CAP, SCREW THE HAMMER GUIDE INTO THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) AND MOBILIZE THE NAIL TO LOOSEN THE NAIL-BLADE CONNECTION. TO DETACH THE BLADE FROM THE BONE USE LIGHT HAMMER BLOWS TO SLIGHTLY DRIVE IN THE BLADE BEFORE REMOVAL OF THE BLADE. FURTHERMORE, THERE WOULD BE EXTRACTION INSTRUMENTS AVAILABLE ON REQUEST. FOR THIS REASON THE COMPLAINT IS DEEMED UNCONFIRMED. 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 THAT DURING THE EXTRACTION OF PROXIMAL FEMORAL NAIL ANTIROTATION BLADE THE LOCKING MECHANISM DIDN¿T OPEN PROPERLY SO THE BLADE WAS EXTRACTED LOCKED WHICH LEFT A LARGE BONE DEFECT THAT HAD TO BE FILLED WITH BONE-SUBSTITUTE. THE TIME FOR THE SURGERY WAS CLEARLY PROLONGED BUT IT IS UNKNOWN THE EXACT AMOUNT OF TIME IT WAS PROLONGED FOR. THE ORIGINAL IMPLANT DATE WAS IN 2012. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308231 PFNA BLADE PERF L120 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 2748496

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention