BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS

    MDR report key: 5060623 · Received September 8, 2015

    Report

    Report Number
    1719045-2015-10578
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Report Date
    August 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED ¿ THE INSTRUMENT WAS FOUND TO BE MISSING THE RATCHET BAR WHICH ATTACHES TO THE HANDLE OF THE DEVICE. THE INSTRUMENT WAS UNABLE TO BE REPAIR AND WAS SENT TO THE COMPLAINT HANDLING UNIT. UPON ARRIVAL THE INSTRUMENT WAS INSPECTED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER THE MISSING COMPONENT IS LIKELY RELATED TO A WORN LEAF SPRING WHICH IS UTILIZED TO RETAIN THE RATCHETING BAR. THE COMPLAINT IS CONFIRMED. THE ROD INTRODUCTION PLIERS ARE A COMPONENT OF THE DUAL-OPENING USS SYSTEM AND ARE UTILIZED FOR CONSTRUCT ASSEMBLY. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION OF MISSING COMPONENTS WAS ABLE TO BE CONFIRMED AS THE RATCHET BAR WAS NOT RETURNED WITH THE DEVICE. THE RATCHET BAR IS RETAINED IN THE HANDLE OF THE DEVICE USING PRESSURE APPLIED BY A LEAF SPRING. INSPECTION UNDER MAGNIFICATION IDENTIFIED WEAR/DEFORMATION ON THE LEAF SPRING WHICH LIKELY ALLOWED THE RATCHET BAR TO FALL OUT AND BEFORE LOST. THE WEAR IS LIKELY RELATED TO THE AGE OF THE DEVICE (MFG 10/2002 ¿ 13 YEARS OLD). RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THE DEVICE. 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

    NO PATIENT INVOLVEMENT . EVENT DATE.: UNKNOWN IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE CUSTOMER REPORTED THE HANDLE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE RATCHET WAS MISSING, THE MALE SPRING WAS WORN ON THE END, THE TUBE WAS BENT, AND THE COLLET WAS STICKING. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON 27-AUG-2015. THE EVALUATION WAS CONFIRMED. SERVICE HISTORY REVIEW ¿ PART NO: 388.509, SERIAL/LOT NO: (B)(4)/4488087. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 9-OCT-2002. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 THE HANDLE WAS BROKEN ON A ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS. THIS WAS FOUND ON SET INSPECTION, THERE WAS NO SURGERY INVOLVED. THE SALES CONSULTANT CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THE ISSUE WAS FOUND OUTSIDE OF THE OPERATING ROOM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592489 ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS PLIERS, SURGICAL HTC SYNTHES MONUMENT 4488087

    Patients

    Seq Age Sex Outcome Treatment
    1