BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWEREASE INSTRUMENTS

    MDR report key: 5395534 · Received January 28, 2016

    Report

    Report Number
    1030489-2016-00311
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 28, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HBE
    PMA / PMN Number
    K111520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 150MM CALIPER MODEL# 500-769-10 ID# 01004 INSPECTOR <(><<)>(><(>&<)><(><<)>)> DATE: (B)(6) 2016 MEASUREMENT: Ø4.12 MM PASS / FAIL - PASS 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: (B)(6) 2016 MEASUREMENT: 52 HRC PASS / FAIL - PASS.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DRIVER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    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 SPINAL FUSION PROCEDURE DUE TO INITIAL DIAGNOSIS OF SCOLIOSIS, THE TIP OF THE SCREWDRIVER BROKE OFF AS THE SURGEON WAS DRIVING A SCREW. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54362 POWEREASE INSTRUMENTS DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC SOFAMOR DANEK USA, INC NA CT11J066

    Patients

    Seq Age Sex Outcome Treatment
    1