BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWEREASE INSTRUMENTS

    MDR report key: 5213107 · Received November 10, 2015

    Report

    Report Number
    1030489-2015-02976
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    October 13, 2015
    Report Date
    November 20, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HBE
    PMA / PMN Number
    K111520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUALLY AND OPTICALLY CONFIRMED APPROXIMATELY ~3MM OF INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. INSPECTION OF THE SHAFT DIAMETER AND MATERIAL HARDNESS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD. GCH ITEM # 10 FEATURE OR DIMENSION : Ø4.15 -.1, SPECIFICATION LOCATION 2342305-01S/M/L, REV.B - PG.1 OF 2, LOC. D2 MEASUREMENT : MITUTOYO 0-25MM OUTSIDE MICROMETER MODEL# 293-180, ID# 01003 INSPECTOR DATE: 20 NOVEMBER 2015. MEASUREMENT: Ø4.131 GCH ITEM # 10 FEATURE OR DIMENSION : HEAT TREAT SPECIFICATION LOCATION 2342305-01S/M/L, REV.B - PG.1 OF 2, - NOTE3 / MSD-PC-113 MEASUREMENT : ROCKWELL 2000 HARDNESS TESTER, MODEL# 2003TA SN# (B)(4), INSPECTOR DATE: 20 NOVEMBER 2015, MEASUREMENT: 51 HRC PASS/FAIL: PASS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LUMBAR SPINAL FUSION , WHILE PLACING THE SCREW IN WITH POWEREASE THE SURGEON TOOK HIS FINGER OFF THE TRIGGER. HE THEN MANUALLY TURNED THE DRIVER AND THE TIP OF THE SCREWDRIVER SNAPPED OFF. HE WAS ABLE TO RECOVER THE PIECE THAT SNAPPED OFF. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743995 POWEREASE INSTRUMENTS DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC SOFAMOR DANEK USA, INC NA CT14K078

    Patients

    Seq Age Sex Outcome Treatment
    1