BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM

    MDR report key: 4141479 · Received October 4, 2014

    Report

    Report Number
    1719045-2014-10492
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION COMPLETED. RESULTS ARE AS FOLLOWS: THE LONG EXPANSION HEAD SCREWDRIVER (03.610.603 LOT 6964122) IS A COMPONENT OF THE CERVICAL SPINE LOCKING PLATE (CLSP) SYSTEM. ACCORDING TO THE SYSTEM TECHNIQUE GUIDE (J7586-B), 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: TOP-LEVEL (03_610_603 REV A) AND SHAFT (03_610_603_1 REV A) USED AT THE TIME OF MANUFACTURE, 9/12, 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 DHF S-05-015 FOUND THAT 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 DEVICE WAS RECEIVED UNDER THE COMPLAINT CATEGORY ¿NICKED/GOUGED/CHIPPED¿. 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. THE LONG EXPANSION HEAD SCREWDRIVER WAS RECEIVED WITH ONE BROKEN AND ONE CHIPPED PRONG. THE COMPLAINT DESCRIPTION STATES THAT THE INSTRUMENT WAS DROPPED WHICH RESULTED IN THE COMPLAINT CONDITION. AFTER REVIEWING THE PRODUCT DRAWINGS, COMPLAINT HISTORY AND SALES DATA, THE INSTRUMENT FAILURE WAS NOT RELATED TO DEVICE DESIGN. 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. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT MAGNUM MANUFACTURING CENTER MANUFACTURED THE SELF-RETAINING SCREWDRIVER, P/N 03.610.603, AND LOT NUMBER 6964122 ON PO #1392766, FOR (B)(4) PIECES DELIVERED SEPTEMBER 27, 2012. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED SEPTEMBER 27, 2012, AND SYNTHES FINAL INSPECTION SHEET # NS021380, REVISION ¿B¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON OCTOBER 5, 2012. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE SELF-RETAINING SCREWDRIVER WAS MADE TO THE SYNTHES DRAWING P/N 03.610.603, REVISION ¿A¿, RELEASED ON JULY 23, 2008. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL STERILE PROCESSING, A SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREW FELL ON THE FLOOR AND THE PRONGS CHIPPED OFF. FRAGMENTS WERE GENERATED HOWEVER, THEY COULD NOT BE RETRIEVED. NO PATIENT OR CASE INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621459 SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM SCREWDRIVERS HXX SYNTHES MONUMENT 6964122

    Patients

    Seq Age Sex Outcome Treatment
    1