BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

    MDR report key: 3843840 · Received June 2, 2014

    Report

    Report Number
    1719045-2014-10241
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: (B)(4). THE DESIGN AND MATERIALS WERE FOUND TO BE APPROPRIATE FOR THIS APPLICATION, AND THE OCCURRENCE RATE OF THIS HAZARD IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. 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 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 THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR (B)(4) LOT 6159825 & 6159827 RELEASED 6/9/2009 X2 .DIENER (B)(4) MANUFACTURED THE ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS, P/N 388.50, AND SYNTHES LOT NUMBERS 6159825 AND 6159827 (SUPPLIER LOT A7SA22) FOR POS 1031757 AND 1041115. THE LOTS WERE INSPECTED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION ¿(B)(4)¿ (DATED (B)(4) 2009 FOR BOTH LOTS). NO MATERIAL REVIEW REPORTS OR NONCONFORMANCE REPORTS WERE GENERATED FOR THESE LOTS. BOTH LOTS WERE RELEASED 6/9/2009. P/N 388.50 IS MADE FROM DRAWING, (B)(4), REVISION ¿(B)(4)¿, RELEASED ON (B)(4) 2008. DRAWING REVISION ¿(B)(4)¿ IS NOT AVAILABLE FOR THIS PART SO REVISION ¿H¿ IS ATTACHED INSTEAD. 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 A PATIENT HAD REVISION SURGERY DUE TO A ROD THAT BROKE BETWEEN L5-S1 ON BOTH SIDES DUE TO PSEUDOARTHROSIS. THE ROD BREAKAGE WAS DISCOVERED DURING A VISIT TO THE SURGEON THROUGH MAGNETIC RESONANCE IMAGING (MRI). DURING THE SURGERY, THE CAPS WERE REMOVED AND THE BROKEN ROD WAS REMOVED, ONE LOOSE SCREW WAS REPLACED. THE RODS WERE REPLACED WITH TITANIUM ALUMINUM NIOBIUM (TAN) RODS AND NEW CAPS WERE PLACED. A FINAL TIGHTENING TORQUE WRENCH WAS USED TO FINAL TIGHTEN ALL THE CAPS. A CAGE WAS PLACED THROUGH THE L5-S1 DISC SPACE. A TRANS-CONNECTOR WAS PLACED BETWEEN L5-S1 SCREWS. IT WAS ALSO REPORTED THAT SEVERAL INSTRUMENTS WERE DAMAGED DURING THE BROKEN ROD REVISION SURGERY AND SEVERAL INSTRUMENT TIPS BROKE OFF. THE SCREWS AND TIPS WERE REMOVED FROM THE CAPS OF THE DEVICES, SOME TIPS LANDED IN THE CAPS, AND PATIENT WITH NO HARM TO THE PATIENT. NO PATIENT HARM WAS REPORTED DURING THE REVISION SURGERY. A TIME DELAY OF 15 MINUTES WAS REPORTED. IT WAS REPORTED THE INSTRUMENTS MAY HAVE BEEN DAMAGED DURING THE PROCESS DUE TO THE DIFFICULT ANGLE OF THE L5-S1 SLOPE. THIS IS REPORT 9 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321291 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS, SURGICAL HTC SYNTHES SELZACH A7SA22

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR