BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 4825055 · Received June 8, 2015

    Report

    Report Number
    2520274-2015-14322
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 18, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. SERVICE HISTORY REVIEW -- LOT #3043585 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN AND CANNOT BE TRACED. THE 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

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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. SYNTHES MANUFACTURING LOCATION COULD NOT BE VERIFIED BASED ON LOT NUMBER AND IS UNKNOWN. 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

    ADDITIONAL NARRATIVE: SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE LOWER SCREW WAS MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS 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 JUNE 29, 2015 FOR FURTHER INVESTIGATION. DEVICE 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. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 387.337, LOT NUMBER 3043585, MANUFACTURING DATE UNKNOWN). THE SYNFRAME ACCESS AND RETRACTOR SYSTEM ALLOWS DIRECT VISUALIZATION AND STABLE RETRACTION FOR LESS INVASIVE SPINE SURGERY. THE CORE FUNCTION OF THE RING DEVICE SYSTEM IS TO PROVIDE A RIGID CONNECTION TO THE DESIRED RETRACTOR BLADES PER THE ASSEMBLY GUIDE. THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT OF ¿SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT THE LOWER SET SCREW OF THE SYNFRAME HALF RING IS MISSING¿. UPON RECEIPT OF THE COMPLAINT DEVICE IT WAS SEEN THAT THE SET SCREWS ARE NO LONGER ATTACHED TO THE DEVICE, THIS COMPLAINT IS CONFIRMED. A REVIEW OF THE MOST CURRENT DESIGN DRAWING WAS PERFORMED, THE DRAWING CALLS OUT AN ADHESIVE (LOCTITE) TO JOIN THE SCREW ASSEMBLY. THIS DESIGN RELIES ON THE ADHESIVE STRENGTH TO KEEP THE SCREW ASSEMBLY CONNECTED IN THE EVENT THE USER CONTINUES TO APPLY TORQUE ON THE SOCKET HEAD SCREW TO DISASSEMBLE THE CONSTRUCT. GIVEN THE 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 OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE. 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 LOWER SET SCREW OF THE SYNFRAME HALF RING WAS MISSING. THERE ARE 3 DEVICES IN THIS COMPLAINT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368228 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR LXH SYNTHES (USA) 3043585

    Patients

    Seq Age Sex Outcome Treatment
    1