BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD

    MDR report key: 5081754 · Received September 16, 2015

    Report

    Report Number
    3003875359-2015-10395
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Report Date
    July 30, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 323.35, 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD, LOT NUMBER 1394253). THE GREEN DRILL SLEEVE (SUBJECT DEVICE) WAS RECEIVED MISSING THE BALL AND SPRING COMPONENT. THESE COMPONENTS ARE RETAINED BY CAULKING THE BALL AND EVIDENCE OF THIS PROCESS COULD BE SEEN ON THE RETURNED SLEEVE. THE BALL/SPRING FUNCTIONALITY IS ALSO INSPECTED PER SE_250779_AA. THE BALL MAY HAVE BECOME WORN FROM USE OR MISHANDLING MAY HAVE CAUSED THE COMPONENTS TO FALL OUT. THE 323.35 DRILL GUIDE IS REFERENCED IN THE VET SMALL FRAG SYSTEM TECHNIQUE GUIDE AS AN AVAILABLE DRILL GUIDE TO BE USED WHILE PRE-DRILLING BONE. THE ASSOCIATED PRODUCT DRAWINGS WERE REVIEWED DURING THE EVALUATION. NO DESIGN ISSUES WERE NOTED. A SERVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE (SYNTHES LOT NO: 5162642, SUPPLIER LOT NO:1394253). THE REVIEW COULD NOT BE COMPLETED AS THIS DEVICE IS A LOT-CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE DEVICE DATE OF MANUFACTURE IS OCT 14, 2005. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. ALTHOUGH THE COMPLAINT CONDITION WAS CONFIRMED, GIVEN THE INFORMATION AVAILABLE, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE. 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

    (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE GREEN PART OF THE DRILL GUIDE DOES NOT STAY ATTACHED. THE COMPLAINT CONDITION WAS NOTICED AFTER A SURGERY MEDICAL DEVICE REPROCESSING (MDR). THERE WAS NO PATIENT OR SURGICAL PROCEDURE INVOLVEMENT. THIS EVENT WAS INITIALLY DETERMINED TO BE A NON-REPORTABLE. REPORTABILITY OF THIS EVENT WAS RE-ASSESSED AFTER THE COMPLETION OF THE PRODUCT DEVELOPMENT INVESTIGATION AND BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT THIS EVENT IS A REPORTABLE MALFUNCTION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612133 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD GUIDE FZX SYNTHES HAGENDORF 1394253

    Patients

    Seq Age Sex Outcome Treatment
    1