BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLSL 11/3.2 F/PFNA BLADE

    MDR report key: 3904644 · Received July 1, 2014

    Report

    Report Number
    9612488-2014-10258
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND NEITHER IMPLANTED NOR EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NONCONFORMANCE 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS:WHILE LOCKING THE BLADE, THE DISTAL PORTION OF THE IMPACTOR (COLORED PORTION) WAS LOOSENED AND DETACHED FROM THE REMAINING IMPACTOR. BUT THE SURGEON TRIED TO LOCK THE BLADE WITH THE IMPACTOR THROUGH SOME OTHER METHOD WHICH RESULTED IN DAMAGE OF THE PROTECTION SLEEVE AND DRILL SLEEVE. AFTER THE SURGERY, IT WAS FOUND THAT THE DRILL SLEEVE IS NOT COMPLETELY INSERTING INTO THE PROTECTION SLEEVE AND IT JAMS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382553 DRILLSL 11/3.2 F/PFNA BLADE GUIDE FZX SYNTHES BETTLACH 2768311

    Patients

    Seq Age Sex Outcome Treatment
    1