BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3891286 · Received June 24, 2014

    Report

    Report Number
    2530088-2014-10170
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE 314.05, LOT#A4GF832 CANNULATED HEXAGONAL SCREWDRIVER WAS RECEIVED INTACT. THE DEVICE SHOWS HEAVY WEAR CONSISTENT WITH SEVENTEEN YEARS OF USE. THE DRIVER TIP ENDS IN A RIPPED JAGGED TIP. THE DEVICE WAS MANUFACTURED IN 6/1997 AND IS 17+ YEARS OLD. THE CANNULATED HEXAGONAL SCREWDRIVER IS A TOOL ROUTINELY USED IN 6.5MM AND 7.3MM CANNULATED SCREW (TECHNIQUE GUIDE J4552-G) PROCEDURES AS WELL AS IN ELEVEN OTHER TECHNIQUE GUIDES. THE DEVICE SHOWS HEAVY WEAR ALONG THE PHENOLIC HANDLE AND THE WORKING LENGTH OF THE DEVICE CONSISTENT WITH OVER SEVENTEEN YEARS OF USE. THE CANNULATED HEXAGONAL SCREWDRIVER (PART #314.05) WAS RETURNED AND REPORTED TO HAVE HAD THE TIP OF THE DEVICE BROKEN OFF DURING THE REMOVAL OF 7.3MM CANNULATED SCREWS. THIS CONDITION IS CONFIRMED; THE DEVICE SHOWS A JAGGED EDGE ENDING IN A POINT WHERE THE TIP OF THE DEVICE WAS RIPPED OFF. THE DEVICE WAS USED TO LOOSEN A SCREW WHICH HAD BEEN IMPLANTED ABOUT FIFTEEN YEARS AGO. THE SCREW LIKELY HAD SIGNIFICANT OSSEOINTEGRATION AND WHEN THE SCREWDRIVER WAS USED TO REMOVE THE SCREW, THE OSSEOUS INGROWTH CAUGHT AND BROKE THE TIP OF THE DEVICE LEADING TO THIS COMPLAINT CONDITION. DRAWING NUMBER 314.05 REV. F WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS LIKELY 17 YEARS OF USE AND OSSEOINTEGRATION INTO THE SCREW RECESS OBSTRUCTED AND ULTIMATELY BROKE THE DEVICE LEADING TO THIS CONFIRMED COMPLAINT; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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

    IT WAS REPORTED THAT WHILE REMOVING THREE CANNULATED SCREWS A HEXAGONAL SCREWDRIVER BROKE. THE PATIENT WAS ORIGINALLY TREATED FOR A HIP FRACTURE ABOUT FIFTEEN YEARS AGO ON AN UNKNOWN DATE WITH THREE 7.3 MM CANNULATED SCREWS. THE PATIENT THEN SUFFERED A RIGHT MID SHAFT FEMUR FRACTURE ON AN UNKNOWN DATE, AND NEEDED A TROCHANTERIC FIXATION NAIL IMPLANTED. IT WAS ALSO REPORTED THAT AS THE SURGEON WAS REMOVING THE THREE CANNULATED SCREWS, THE TIP OF THE SCREWDRIVER BROKE. THE TIP OF THE SCREWDRIVER WAS RETRIEVED. THERE WERE NO ISSUES WITH THE CANNULATED SCREWS THEY WERE JUST REMOVED IN ORDER TO INSERT THE TROCHANTERIC FIXATION NAIL. THERE WAS A REPORT OF A ONE MINUTE SURGICAL DELAY. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368247 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES BRANDYWINE A4GF832

    Patients

    Seq Age Sex Outcome Treatment
    1