BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 4508688 · Received February 11, 2015

    Report

    Report Number
    2520274-2015-10892
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNONIS.(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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SYNFRAME ACCESS AND RETRACTOR SYSTEM ALLOWS DIRECT VISUALIZATION AND STABLE RETRACTION FOR LESS INVASIVE SPINE SURGERY. THE CORE FUNCTION OF THE RING DEVICE IS TO PROVIDE A RIGID CONNECTION TO THE DESIRED RETRACTOR BLADES. ONE SYNFRAME HALF RING (PART# 387.337, LOT# 1941932 MFG DATE OCTOBER 2010) WAS RETURNED WITH THE COMPLAINT THAT ¿THE SYNFRAME HALF RING IS MISSING SCREWS. ITEM WAS DISCOVERED POST-OPERATIVE.¿ THE DEVICE WAS SENT TO SERVICE AND REPAIR AND WAS NOT REPAIRABLE. UPON RECEIPT OF THIS DEVICE IT WAS SEEN THAT THE SCREWS ARE NO LONGER ATTACHED TO THE HALF RING, THIS COMPLAINT IS CONFIRMED. THE ASSOCIATED DRAWING WAS REVIEWED. THE DRAWING CALLS OUT THE APPROPRIATE MATERIALS, DIMENSIONS, AND FINISHING PROCESSES FOR THE PROPER MANUFACTURING OF THIS INSTRUMENT. GIVEN THE MINIMUM AGE OF THIS DEVICE IT IS MOST LIKELY THAT FROM YEARS OF USE AND STERILIZATION CYCLES, THE ADHESIVE STRENGTH DIMINISHED, LEADING TO THIS CONDITION. THE DESIGN WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE OF THIS INSTRUMENT. 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. A SERVICE HISTORY REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE LOT #1941932. A SERVICE HISTORY REVIEW CANNOT BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE SERVICE HISTORY HAS BEEN REQUESTED. A SERVICE AND REPAIR EVALUATION WAS PERFORMED; THE CUSTOMER REPORTED THE SCREWS WERE MISSING. THE REPAIR TECHNICIAN REPORTED THREADS STRIPPED AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE EVALUATION WAS CONFIRMED. 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 BY THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE SYNFRAME HALF RING IS MISSING SCREWS. ITEM WAS DISCOVERED POST OPERATIVELY. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS FOR 2 OF 2 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102138 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR. LXH SYNTHES MONUMENT 1941932

    Patients

    Seq Age Sex Outcome Treatment
    1