BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM

    MDR report key: 4297991 · Received December 4, 2014

    Report

    Report Number
    1719045-2014-10658
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 7, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT (B)(4). 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A LONG EXPANSION HEAD SCREWDRIVER (03.610.603 LOT 4790802) WAS RECEIVED WITH ONE BROKEN PRONG ON THE DISTAL TIP. PER THE TECHNIQUE GUIDE, THE LONG EXPANSION HEAD SCREWDRIVER (03.610.603 LOT 4790802) IS A COMPONENT OF THE CERVICAL SPINE LOCKING PLATE (CLSP) SYSTEM. THE DRIVER IS USED TO INSERT AND REMOVE THE CSLP QUICK LOCK SCREWS AS AN ALTERNATIVE INSTRUMENT TO THE SHORTER, CANNULATED EXPANSION HEAD SCREWDRIVER (03.610.602). PRODUCT DRAWINGS FOR THE LONG EXPANSION HEAD SCREWDRIVER AND SHAFT USED THAT WERE USED AT THE TIME OF MANUFACTURE WERE REVIEWED AND FOUND TO BE SUITABLE FOR THEIR INTENDED USE. THE LONG EXPANSION HEAD SCREWDRIVER WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. REVIEW OF CADAVER LAB TESTING FOR 03.610.602, WHICH HAS THE SAME TIP GEOMETRY, MATERIAL, AND HEAT TREAT AS 03.610.603, SHOWED THAT THE DRIVER IS ABLE TO ADEQUATELY INSERT AND SEAT THE CSLP SCREWS. CUSTOM 465 IS ALSO AN APPROPRIATE MATERIAL AS THE DUCTILITY ALLOWS FOR DEFORMATION BEFORE BREAKAGE AND REDUCES THE RISK OF A PRONG BREAKING. THE COMPLAINT DESCRIPTION NOTES THAT THE INSTRUMENT WAS DROPPED WHICH LED TO THE COMPLAINT CONDITION. AS SUCH THE FAILURE WAS NOT RELATED TO THE PRODUCT DESIGN. AFTER REVIEWING THE PRODUCT DRAWINGS, COMPLAINT HISTORY AND SALES DATA, THE INSTRUMENT FAILURE WAS NOT RELATED TO DEVICE DESIGN. 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

    IT WAS REPORTED THAT TWO SCREWDRIVERS WERE DROPPED AND BROKE. IT WAS REPORTED THAT THE EXTRACTION SCREWDRIVER WAS DROPPED AND THE INNER SHAFT BROKE. IT WAS REPORTED THAT THE SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM WAS DROPPED AND THE TIP BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783359 SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM SCREWDRIVERS HXX SYNTHES MONUMENT 4790802

    Patients

    Seq Age Sex Outcome Treatment
    1