BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3832159 · Received May 27, 2014

    Report

    Report Number
    8030965-2014-00422
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    September 6, 2013
    Report Date
    October 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. RECEIVED FACILITY COMPLETED QUESTIONNAIRE ON (B)(4) 2013 WHICH PROVIDED DETAILS THAT DEEMED NON-REPORTABLE STATUS TO A REPORTABLE MALFUNCTION CASE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATIONS HAVE BEEN PROCESSED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION/SYNTHES POWER TOOL EVALUATION WAS CONDUCTED. THE REPORT STATED THE DEVICE CONDITION WAS RECEIVED AS BLEMISHED HOUSING. IT CONCLUDED: THE REPORTER'S COMPLAINT THAT THE UNIT IS NOT WORKING PROPERLY WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. A SERVICE HISTORY RECORD REVIEW WAS COMPLETED. IT REPORTED THE DEVICE COULD NOT SECURE WIRE WHEN DRILLING WITH 1.6MM WIRE IN SETTING . IT CONCLUDED: A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS 20-MAR-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE DEVICE HISTORY RECORD REVIEW. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 BY THE FACILITY BUYER THAT THE QUICK COUPLING FOR K-WIRES DEVICE IS NOT WORKING PROPERLY. ON (B)(6) 2013 AN UPDATE WAS PROVIDED BY A FACILITY COMPLETED QUESTIONNAIRE: FACILITY REPORTS THAT THE PIN DRIVER IS LOCKING UP AND NOT ADVANCING THE PIN DURING SURGERY. A SECOND BATTERY WAS OPENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. AFTER THE CASE WAS FINISHED, OIL WAS PUT ON THE DRIVER AND IT REPORTEDLY WAS THEN ABLE TO SPIN. THIS REPORT IS FOR ONE INSTRUMENT. THIS IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310563 QUICK COUPLING FOR K-WIRES HWE SYNTHES GMBH 08604

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR