BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER STANDARD

    MDR report key: 3812431 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11440
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE SCREWDRIVER IS BROKEN AS COMPLAINT. THE MACROSCOPIC ASSESSMENT REVEALED SLIGHT DAMAGE AT THE FRACTURE AREA, PROBABLY DUE TO THE RELATIVE MOTION AND CONTACT OF THE FRAGMENT AND THE SHAFT AFTER THE BREAKAGE OCCURRED. THE FRACTOGRAPHIC EXAMINATIONS BY SCANNING ELECTRON MICROSCOPE (SEM) REVEALED TORSIONAL PROGRESSION LINES ALONG THE FRACTURE AREA AT THE DIFFERENT COGS OF THE HEXAGONAL TIP. AT HIGHER MAGNIFICATION DUCTILE HONEY COMBS COULD BE DOCUMENTED WITH SMALL CARBIDES PRESENT ON THE ENTIRE FRACTURE SURFACE, AN UNEQUIVOCAL INDICATION OF A DUCTILE FORCED FRACTURE MECHANISM UNDER A COMBINATION OF TORSIONAL AND LATERAL LOAD. THE MICROSTRUCTURE OF THE USED MATERIAL WAS EXAMINED IN A CROSS SECTION AND FOUND TO BE ACCORDING TO THE STANDARDS. THERE WERE NO IRREGULARITIES OR SIGNS OF EMBRITTLEMENT EVIDENT. THE DETERMINED HARDNESS WAS ACCORDING TO THE DRAWING; HENCE IT IS LIKELY THE HEAT TREATMENT OF THE STEEL WAS PERFORMED CORRECTLY. THE PERFORMED INVESTIGATION COULD NOT DETECT ANY MATERIAL FAULTS. THE PRESENT SCREWDRIVER BROKE ACCORDING TO A DUCTILE FRACTURE MECHANISM DURING AN INSTANTANEOUS OVERLOADING. IT IS LIKELY THAT THE INSTRUMENT BROKE UNDER NOT INTENDED LOAD CONDITIONS, PROBABLY CAUSED BY NOT IDEAL ORIENTATION OF THE SCREWDRIVER TO THE CREW OF INSUFFICIENT GUIDANCE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING SURGICAL TECHNIQUE. GIVEN THE INFORMATION AND INVESTIGATION RESULTS PROVIDED, THERE IS NO REASON TO BELIEVE THE ROOT CAUSE IS INSTRUMENT RELATED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND. THE INSTRUMENT WAS MANUFACTURED IN JANUARY 2012. NO PRODUCT FAULT COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE SCREWDRIVER SHAFT IN QUESTION BROKE OFF DURING FINAL TIGHTENING OF A SCREW. THE SURGEON USED A BACKUP OF THE SAME PRODUCT AND COMPLETED THE OPERATION THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291659 STRAIGHT TIP T25 DRIVER STANDARD SCREWDRIVERS HXX SYNTHES HAGENDORF 7705747

    Patients

    Seq Age Sex Outcome Treatment
    1