BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    MDR report key: 4028251 · Received August 21, 2014

    Report

    Report Number
    3000270450-2014-10089
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    ADDITIONAL NARRATIVE: THE DHR SHOWED NOTHING OUT OF THE ORDINARY FROM THE MANUFACTURING PROCESS AND PASSED THE DIMENSIONAL INSPECTION FOR LOT U113727. THERE WERE NO QUARANTINE ISSUES DURING THE MANUFACTURING PROCESS FOR THIS LOT. I REVIEWED THE RAW MATERIAL CERTIFICATIONS IN THE DEVICE HISTORY RECORD AND VERIFIED THE MATERIAL TO BE (B)(4). THE HARDNESS CHECK¿S WITHIN PRINT SPECIFICATION ((B)(4)). A MANUFACTURING EVALUATION WAS COMPLETED: VISUAL INSPECTION DID NOT REVEAL ANY FAULTS OR IRREGULARITIES. THE DRILL BIT IS NOT AFFECTED BY THE COMPLAINT CONDITION. 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

    THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A REVISION SURGICAL PROCEDURE TO REPLACE A BROKEN IMPLANTED PLATE, IT WAS OBSERVED THAT THE RADIOLUCENT DRIVE DEVICE STOPPED ROTATING DURING DRILLING OF THE CORTICAL BONE. ACCORDING TO THE REPORT, A NEW PLATE DEVICE WAS INSERTED FOR RE-FIXATION AFTER THE REMOVAL OF THE BROKEN PLATE. WHEN THE SURGEON WAS ATTEMPTING TO DRILL THE SECOND HOLE ON THE MOST DISTAL SIDE FOR DISTAL LOCKING, IT WAS OBSERVED THAT THE DRILL BIT DEVICE, WHEN IN USE WITH RADIOLUCENT DRIVE DEVICE, COULD NOT DRILL THE CORTICAL BONE ¿WELL.¿ IT WAS FURTHER REPORTED THAT THE DEVICES ¿FINALLY STOPPED ROTATING¿. IT WAS CLARIFIED THAT THE ATTACHMENT DEVICE AND THE DRILL BIT DEVICE WERE REMOVED FROM THE RADIOLUCENT DRIVE DEVICE, AND THE RADIOLUCENT DRIVE DEVICE FUNCTIONED PROPERLY. THE SURGEON RETRIED WITH THE ¿DRILL ASSEMBLY¿ AND WAS ABLE TO DRILL THROUGH THE SECOND HOLE SUCCESSFULLY. HOWEVER, IT WAS REPORTED THAT THE SAME ALLEGED MALFUNCTION OCCURRED WHEN THE SURGEON ATTEMPTED TO DRILL THE FOURTH HOLE AND THE ¿DRILL BECOME DYSFUNCTIONAL.¿ IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR PROXIMAL USE TO COMPLETE TO THE PROCEDURE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SURGERY WAS EXTENDED FOR TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506996 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES SELZACH U113727

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR PLATE DEVICE| ATTACHMENT DEVICE| RADIOLUCENT DRIVE DEVICE| DRILL BIT DEVICE