BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD

    MDR report key: 4997981 · Received August 12, 2015

    Report

    Report Number
    3003875359-2015-10365
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    July 27, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 11MARCH2013. 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 323.350, 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD, LOT NUMBER 8232998). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION, ¿MISSING THE BALL COMPONENT THAT LOCKS THE GREEN DRILL SLEEVE IN PLACE.¿ THE 323.35 DRILL GUIDE IS REFERENCED IN THE VET SMALL FRAG SYSTEM PER THE TECHNIQUE GUIDE AS AN AVAILABLE DRILL GUIDE TO BE USED WHILE PRE-DRILLING BONE. PRODUCT DRAWINGS WERE REVIEWED DURING THE EVALUATION. NO DESIGN ISSUES WERE NOTED. THE GREEN DRILL SLEEVE WAS 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. THE BALL MAY HAVE BECOME WORN FROM USE OR MISHANDLING MAY HAVE CAUSED THE COMPONENTS TO FALL OUT. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. GIVEN THE INFORMATION AVAILABLE, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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) REPORTED THAT THE GREEN PART OF THE DRILL GUIDE IS MISSING THE BALL INSIDE. THIS EVENT DID NOT INVOLVE A PATIENT OR DELAY ANY PENDING SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527814 3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD GUIDE FZX SYNTHES HAGENDORF 8232998

    Patients

    Seq Age Sex Outcome Treatment
    1