BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER SURGICAL'S STREAMLINE MIS THREADED SCREW INSERTER

    MDR report key: 6445408 · Received March 30, 2017

    Report

    Report Number
    1833824-2017-00009
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    November 15, 2016
    Report Date
    March 30, 2017
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
    Product Code
    NKB
    PMA / PMN Number
    K130286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OCCURRENCE TOOK PLACE IN (B)(6). IT WAS DISCOVERED THAT THE SCREW INSERTER DRIVE END WAS MODIFIED AFTER BEING DISTRIBUTED BY PIONEER SURGICAL TECHNOLOGY BY MACHINING THE END DOWN IN ORDER TO BE ABLE TO BE ATTACHED TO A POWER DRIVER IN THE OPERATING ROOM. THIS WAS NOT THE DESIGN OF THE INSTRUMENT NOR WAS IT MANUFACTURED TO ATTACH TO A POWER DRIVER. THE INSTRUMENT WAS NOT ABLE TO BE INSPECTED SINCE IT WAS NOT RETURNED. ACCORDING TO THE INFORMATION THAT WAS ABLE TO BE GATHERED THE OCCURRENCE DID NOT IN ANY WAY HARM THE PATIENT AND THE SURGERY WAS COMPLETED WITH NO DELAYS REPORTED. NO DHR REVIEW COULD BE DONE SINCE THE LOT NUMBER OF THIS DRIVER WAS NOT REPORTED TO PIONEER SURGICAL TECHNOLOGY. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IN (B)(6) DURING A POSTERIOR SPINAL FIXATION SURGERY, THE PEDICLE SCREW INSERTER WAS BEING USED TO GAIN SOME MORE DEPTH ON THE SCREW AFTER THE POWER DRIVER HAD REACHED ITS CAPACITY. THE DRIVER HEAD BROKE OFF INSTANTLY WHICH WAS LODGED AND LEFT IN THE TOP OF THE TULIP OF THE SCREW. THE LOCKING SET SCREW WAS THEN PLACED OVER THE BROKEN TIP AND LOCKED DOWN. THERE WAS NO INJURY TO THE PATIENT NOR DID THIS CAUSE ANY SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229654 PIONEER SURGICAL'S STREAMLINE MIS THREADED SCREW INSERTER SCREW INSERTER NKB PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) 05-SCREW-INS-THRD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1