BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSS TAPS, POWER 4.5MM

    MDR report key: 3367546 · Received September 16, 2013

    Report

    Report Number
    3005739886-2013-00030
    Event Type
    Injury
    Date Received
    September 16, 2013
    Date of Event
    August 17, 2013
    Report Date
    August 23, 2013
    Manufacturer
    SPINAL USA, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEER'S EVAL OF THE RETURNED INSTRUMENT NOTED THE TAP FRACTURED IN THE THREADED PORTION APPROX 27.7MM FROM THE TIP. THE FRACTURE SHOWS SIGNS OF FAILING IN BENDING AND NOT PURE TORSION AS A SLIGHT ELONGATED LIP IS VISIBLE. AS INFO PROVIDED INDICATES THAT THERE WAS AN ISSUE WITH THE DIRECTION OF THE DRILL CAUSING THE POWER DRILL TO SLIP OUT OF THE SURGEON'S HAND, THIS LIKELY ACCOUNTED FOR THE BENDING MOMENT WITH CAUSED THE FRACTURE. REVIEW OF THE RECEIVING INSPECTION REPORT FOR C1739-45 FOUND ONE (1) UNIT OF THIS LOT WAS RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION ON (B)(6) 2013 WITH NO DEVIATION OR ANOMALIES. THIS CUSTOM WAS MANUFACTURED BY MODIFYING A STANDARD LINE PSST45 4.5MM TAP, LOT 32532. REVIEW OF THE RECEIVING INSPECTION REPORTS FOR PSST LOT 32532, FOUND A TOTAL OF ONE HUNDRED SIXTY-TWO (162) UNITS WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION ON (B)(6) 2013 WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOR THE STANDARD LINE 4.5MM TAP PART NUMBER THAT WAS MODIFIED TO MAKE THE COMPLAINT LOT DID NOT REVEAL ANY ADD'L ISSUES OF THIS NATURE REPORTED FOR THE LOT USED. NOR WAS A TREND FOR REPORTS OF THIS NATURE REGARDLESS OF LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THERE WERE TWO POWER DRILLS USED DURING THE PROCEDURE, ONE BATTERY POWERED, ONE CORDED. EACH POWER DRILL HAS A DIFFERENT FORWARD AND REVERSE SWITCH MECHANISM. THE SURGEON THOUGHT THAT THE POWER DRILL WAS SET TO REVERSE BUT WAS ACTUALLY SET TO FORWARD. THIS MISTAKE IN DIRECTION CAUSED THE DRILL TO SLIP FROM THE SURGEON'S HAND RESULTING IN FRACTURE OF THE TAP AT THE TIP. THE SURGEON TRIED EXTENSIVELY TO REMOVE THE TIP FROM THE PT'S BONE, BUT WAS UNSUCCESSFUL. THE FRACTURED TIP REMAINS IN THE PT'S BONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ROD BRIDGING THE PEDICLE WITHOUT A SCREW. A DELAY IN THE PROCEDURE OF APPROX TWO (2) HOURS WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464961 PSS TAPS, POWER 4.5MM CUSTOM SURGICAL INSTRUMENT LXH SPINAL USA, INC. MG6312-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R