BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER

    MDR report key: 6895525 · Received September 26, 2017

    Report

    Report Number
    1719045-2017-10985
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Report Date
    September 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCT 17, 2017. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 1011549 (SYNTHES LOT NUMBER IS 5889774). MANUFACTURING LOCATION: MONUMENT (SUPPLIER: PRECIMED). DATE OF MANUFACTURE: 18 NOV 2008. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER, PART NUMBER 357.417, LOT NUMBER 1011549). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED DEVICES AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. VISUAL INSPECTION AT CQ WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT CONDITION. THERE IS NO EVIDENCE OF LEAKING FLUID AT THE AREA REPORTED. THE PROXIMAL END JUNCTION OF THE BLACK RUBBER PROTECTING THE COIL APPEARS TO HAVE A TIGHT SEAL WITH THE ADJACENT METALLIC SECTION OF RECEIVED BOTH SCREWDRIVERS. NO FLUID OR GAPS WERE NOTICED UNDER 5X MAGNIFICATION. BOTH DEVICES SHOW CUMULATIVE WEAR COMMENSURATE WITH NEARLY 9 YEARS OF FIELD USE AND REPEATED STERILIZATION CYCLES AS THE HANDLES ARE DARKENED AND THE METALLIC AREAS ON THE DEVICES SHOW SCRATCHES AND WEAR MARKS. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. SCREWDRIVER ASSEMBLY DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT AS THIS COMPLAINT IS UNCONFIRMED. IT IS POSSIBLE THAT THE SEAL BETWEEN THE SILICONE OVER MOLDED SLEEVE AND METALLIC SCREWDRIVER SHOULDER HAS BEEN COMPROMISED DUE TO NEARLY 9 YEARS OF USE AND REPEATED STERILIZATION CYCLES. HOWEVER, THIS CANNOT BE CONFIRMED AS NO EVIDENCE OF ANY LEAKING FLUID WAS NOTICEABLE ON THE RETURNED DEVICES. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. UNKNOWN. OTHER UDI: (B)(4) UNKNOWN, UDI UNAVAILABLE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 5.0MM HEXAGONAL FLEXIBLE SCREWDRIVER (WITH RUBBER COVERING THE COIL) SEEMS TO BE LEAKING (UNKNOWN LIQUID) AT THE PROXIMAL END JUNCTION OF THE BLACK RUBBER PROTECTING THE COIL FROM BEING CONTAMINATED. THE CONCERNED INSTRUMENT IS IN BOTH TROCHANTERIC FIXATION NAIL (TFN) SETS AT THIS HOSPITAL HAVE THE SAME LEAKING ISSUE. THIS WAS REPORTED FROM THE STERILIZATION DEPT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675259 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 1011549

    Patients

    Seq Age Sex Outcome Treatment
    1