BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES

    MDR report key: 4171320 · Received October 14, 2014

    Report

    Report Number
    1719045-2014-10508
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES IS FOR USE WITH THE MATRIXRIB SYSTEM AND IS DESIGNED TO BE THREADED INTO THE PLATE TO ENSURE SAFE DRILLING AND ALIGNMENT OF THE DRILL HOLE WITH THE PLATE HOLE, AND IS REMOVED AFTER DRILLING. ONE 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES WAS RETURNED WITH A PIECE OF THE THREADED PORTION BROKE OFF OF THE DRILL GUIDE. UPON RECEIPT OF THE DEVICE THIS COMPLAINT WAS CONFIRMED AS A FRACTION OF THREE LEVELS OF THE DISTAL THREADING OF THIS PART HAS TORN AWAY FROM THE DEVICE, IS NO LONGER ATTACHED AND WAS NOT RETURNED. THE DRAWING FOR THIS PART WAS REVIEWED AND THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE SEEN TO BE ADEQUATE FOR THE INTENDED USE OF THIS DEVICE. IT IS UNKNOWN AS TO WHAT CAUSED THE FAILURE OF THIS DEVICE, ROUGH HANDLING DURING PROCESSING IS A ROOT CAUSE LOOKING AT THE REMAINING THREADING OF THE DEVICE, OFF-AXIS FORCE WHILE THE GUIDE WAS PARTIALLY ENGAGED WOULD ALSO LEAD TO THIS CONDITION. THIS COMPLAINT IS CONFIRMED, HOWEVER THE DESIGN OF THIS DEVICE WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT MAGNUM MANUFACTURING CENTER MANUFACTURED THE THREADED DRILL GUIDE, PART #03.632.036, AND LOT #6156203 (SUPPLIER LOT #4793801) ON PO #1017071, FOR 104 PIECES DELIVERED JUNE 1, 2009. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED JUNE 3, 2009, AND SYNTHES FINAL INSPECTION SHEET #NS021413, REVISION ¿B¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 4, 2009. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE THREADED DRILL GUIDE WAS MADE TO THE SYNTHES DRAWING 03.501.033, REVISION ¿D¿, RELEASED ON FEBRUARY 27, 2009. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY CONTACTED THE SALES CONSULTANT AND INFORMED HIM THE PART BECAME DAMAGED DURING PROCESSING. A PIECE OF THE THREADED PORTION BROKE OFF OF THE DRILL GUIDE. NO PATIENT INVOLVED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650583 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES GUIDE FZX SYNTHES MONUMENT 4793801

    Patients

    Seq Age Sex Outcome Treatment
    1