BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH WITH STRAIGHT HANDLE-6MM WIDTH ACROSS FLATS

    MDR report key: 4163639 · Received October 10, 2014

    Report

    Report Number
    1719045-2014-10502
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORD (DHR ) REVIEW FOR PART 388.14 - SOCKET WRENCH WITH STRAIGHT HANDLE - LOT 4329760 (SUPPLIER LOT #LM002450) - COMACT-(B)(4). (B)(6) MEDICAL PRODUCTS, INC. MANUFACTURED THE SOCKET WRENCH WITH STRAIGHT HANDLE, PART #388.14, AND LOT #5560954 (SUPPLIER LOT #LM002450) ON PO #(B)(4), FOR 60 PIECES DELIVERED OCTOBER 3, 2001 AND ON PO #(B)(4), FOR 10 PIECES DELIVERED DECEMBER 21, 2001. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED SEPTEMBER 27, 2001 (PO #(B)(4)) AND DATED NOVEMBER 9, 2001 (PO #(B)(4)) AND TO THE SYNTHES FINAL INSPECTION SHEET # (B)(4), REVISION ¿D¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON OCTOBER 24, 2001 (PO #(B)(4)) AND DATED FEBRUARY 18, 2002 (PO #(B)(4)). MATERIAL REVIEW REPORT (MRR) (B)(4) WAS ISSUED (B)(6) 2001 FOR UNDERSIZE HANDLE; 60/60 DISPOSITIONED TO USE AS IS, SINCE THIS WAS JUDGED TO BE NO EFFECT TO FUNCTION. THIS MRR CLOSED (B)(6) 2001. MRR (B)(4) WAS ISSUED (B)(6) 2001 FOR UNDERSIZE HANDLE; 10/10 DISPOSITIONED TO USE AS IS, SINCE EVALUATION SHOWED THAT THIS WAS A NEW STYLE HANDLE, AND THE DRAWING WAS UPDATED. THIS MRR CLOSED(B)(6) 2002. THE SOCKET WRENCH WITH STRAIGHT HANDLE WAS MADE TO THE SYNTHES DRAWING P/N 388.14, REVISION ¿B¿, RELEASED ON (B)(6) 2000. REVISION ¿B¿ OF THE DRAWING IS NOT FILED IN WINDCHILL CORRECTLY (REVISION ¿C¿ IS FILED AS ¿B¿ AND IS INCLUDED WITH THIS REVIEW AS REFERENCE). THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE INSTRUMENT WAS RETURNED WITH THE HANDLE BROKEN IN THREE PIECES. THE PIN IS NO LONGER ASSEMBLED TO THE HANDLE OR SHAFT. THE SHAFT HAS WEAR CONSISTENT WITH NORMAL USE. THE SOCKET WRENCH WITH STRAIGHT HANDLE, 6 MM (PART# 388.14, LOT# LM002450) WAS RETURNED FOR THE HANDLE REPORTEDLY BREAKING. THIS SOCKET WRENCH IS USED TO ASSEMBLE THE SYNFRAME ACCESS AND RETRACTOR SYSTEM, WHICH ALLOWS DIRECT VISUALIZATION AND STABLE RETRACTION FOR LESS INVASIVE SPINE SURGERY, ELIMINATING THE NEED FOR LARGE HANDLE HELD RETRACTORS. SPECIFICALLY, THE SOCKET WRENCH IS USED TO TIGHTEN AND LOOSEN THE SWIVELING CLAMP OF THE GUIDE ROD (SYNFRAME TECHNIQUE GUIDE (B)(4)). THE INSTRUMENT WAS RETURNED WITH THE HANDLE BROKEN IN THREE PIECES AND THE PIN NO LONGER ATTACHED TO THE SHAFT OR HANDLE. DUE TO THE MATERIAL OF THE HANDLE AND THE ENVIRONMENT THAT THIS DEVICE IS EXPOSED TO WHILE BEING AUTOCLAVED, THERE IS A RISK OF MOISTURE ABSORPTION INTO THE HANDLE AS WELL AS EXPANSION AND CONTRACTION OF THE MATERIAL DURING STERILIZATION AND COOLING TO ROOM TEMPERATURE. THE COMBINATION OF THESE FACTORS OVER THE COURSE OF MANY YEARS MAY DEGRADE THE PHENOLIC MATERIAL. THE INSTRUMENT WAS MANUFACTURED UNDER 388_14 REV. B ALTHOUGH THERE HAVE NOT BEEN ANY MATERIAL CHANGES SINCE THE RELEASE OF THE RETURNED INSTRUMENT (CURRENT DRAWING 388_14 REV. E). THE FRACTURE LINES SHOW THAT THE BREAK OCCURRED TORSIONAL ABOUT THE PIN OF THE WRENCH. THE DESIGN IS ADEQUATE FOR THE INSTRUMENT¿S INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. WHILE IT IS POSSIBLE THAT DETERIORATION OF THE MATERIAL CAUSED THE COMPLAINT CONDITION, TECHNIQUE AND OTHER POSSIBLE CONTRIBUTING FACTORS REMAIN UNKNOWN. 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 THE ANTERIOR APPROACH OF A PROCEDURE WITH A SYNFRAME RETRACTOR, THE LOCKING NUT ON THE ADJUSTABLE SYNFRAME EXTENSION WAS FOUND LOOSE AND A SOCKET WRENCH HANDLE BROKE. THE PATIENT UNDERWENT AN L3 CORPECTOMY ON (B)(6) 2014 FOR AN L3 BURST FRACTURE. DURING THE ANTERIOR APPROACH, THE LOCKING NUT ON THE ADJUSTABLE SYNFRAME EXTENSION THAT SECURES THE HINGE APPEARED TO BE FORCED UNDONE AT SOME POINT IN TIME. THE PART FUNCTIONED PROPERLY, HOWEVER, THE LOCKING NUT SHOULD NOT BE ABLE TO BE UNSCREWED FROM THE PART. THE SECOND ISSUE THAT AROSE DURING THE PROCEDURE WAS THAT THE SOCKET WRENCH HANDLE BROKE OFF THE SHAFT WHILE TIGHTENING UP THE SYNFRAME GUIDE ROD. ALL THE PIECES OF THE HANDLE WERE RETRIEVED, AND A NEW HANDLE FROM ANOTHER STERILE SET WAS USED. REPORTEDLY, THE DELAY WAS MINIMAL, NO MORE THAN 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640337 SOCKET WRENCH WITH STRAIGHT HANDLE-6MM WIDTH ACROSS FLATS TRAY,SURGICAL INSTRUMENT FSM SYNTHES MONUMENT LM002450

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR