BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 2924643 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00165
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AVALIGN TECHNOLOGIES, NEMCOMED, MANUFACTURED THE RETAINING SLEEVE FOR MATRIX. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND. OUR INVESTIGATION OF THE RETURNED RETAINING SLEEVES HAS SHOWN THAT THE FRONT THREADED PARTS OF BOTH ARE BROKEN OFF. WE ARE AWARE OF THE FACT THAT THIS IS A RATHER DELICATE DESIGN WHERE THE THREADED PART IS THIN WALLED, THEREFORE IT IS IMPORTANT TO FOLLOW THE RELEVANT OP INSTRUCTION. ALSO THE TIPS OF THE RETURNED SCREWDRIVERS ARE DAMAGED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. WE CAN ONLY SUPPOSE, ACCORDING TO THE GIVEN FEEDBACK, THAT THE DAMAGE WAS CAUSED DUE TO TOO MUCH APPLIED MECHANICAL FORCE, OFTEN USED INSTRUMENT. THE INSTRUMENT WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT WAS DETECTED. DEVICE IS AN INSTRUMENT AND IS NOT A SINGLE USE ITEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: THE RETAINING SLEEVES GOT DAMAGED DURING OFTEN USE. THE THREADED TIPS ARE BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30083 RETAIN-SLEEVE LONG F/MATRIX 5.5 RETAIN-SLEEVE NKB SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1