BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS

    MDR report key: 3690745 · Received March 20, 2014

    Report

    Report Number
    8030965-2014-10045
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    February 26, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE MATERIAL AND DESIGN ARE ADEQUATE FOR THE INTENDED USE OF THIS DEVICE. THE SELF-RETAINING SCREWDRIVERS WERE RETURNED AND THE COMPLAINT OF BROKEN TIP WAS CONFIRMED. PER THE TECHNIQUE GUIDE, P/N 03.610.601 (LOCKING DRIVER) SHOULD BE USED FIRST. IF THE SELF-RETAINING SCREWDRIVER IS NOT FULLY SEATED IN PLACE AND/OR COAXIAL WITH SCREW, THE DRIVER IS SUSCEPTIBLE TO BENDING FAILURE OF THE PRONGS. PER PREVIOUS EVALUATION, THE TORQUE FORCE FOR A SHEAR FAILURE OF THE PRONGS FOR A FULLY SEATED IN-PLACE DRIVER WAS CALCULATED AS 4.8NM. BASED ON THE INFORMATION ABOVE, THE ROOT CAUSE FOR THIS FAILURE IS UNKNOWN BUT THE MOST LIKELY ROOT CAUSE IS EXCESSIVE FORCE BY CLINICIAN. SINCE IT IS UNKNOWN IF THE DRIVER WAS FULLY SEATED AND SURGICAL TECHNIQUE OF CLINICIAN THIS COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT. IN CONCLUSION, PROPER USE IS CRITICAL TO THE SUCCESS OF THIS DEVICE, THIS COMPLAINT COULD HAVE BEEN CAUSED BY IMPROPER TECHNIQUE (EXCESSIVE FORCE, OVER TORQUING AND/OR IMPROPER MANIPULATION). THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. 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 LOT NUMBERS THAT WERE RECEIVED FOR THE SCREWDRIVERS ARE 8516655, 7806483, 1822248 AND 7806483. SYNTHES CANNOT IDENTIFY WHICH OF THE LOT NUMBERS IS FOR THE COMPLAINED DEVICE. 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: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. (B)(4). 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

    THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4). THIS REPORT IS FOR ONE OF THREE SCREWDRIVERS WITH A BROKEN TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL DAMAGED INSTRUMENTS WERE FOUND AT THE FACILITY'S STERILE DEPARTMENT. THERE ARE A TOTAL OF FOUR CERVICAL SPINE LOCKING PLATE SCREWDRIVERS OF WHICH THREE HAVE BENT TIPS AND ONE HAS THE TIP BROKEN OFF. THERE ARE TWO DRILL GUIDES THAT HAVE BROKEN TIPS. THERE IS ONE ANTEGRA HANDLE WITH A DRILL BIT JAMMED INSIDE OF IT WHICH WAS NOTICED AFTER IT WAS WASHED. THERE WAS NO IMPLICATION THAT THESE EVENTS OCCURED DURING PROCEDURES AND INVOLVED ANY PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR THE SCREWDRIVER WITH BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167423 SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS SCREWDRIVERS HXX SYNTHES HAGENDORF 7806483

    Patients

    Seq Age Sex Outcome Treatment
    1