BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME INSULATED TABLE CLAMP

    MDR report key: 8561364 · Received April 29, 2019

    Report

    Report Number
    2939274-2019-57717
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Report Date
    March 11, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034771120
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED DEVICE. OCCUPATION: SYNTHE SALES REP. INVESTIGATION SUMMARY COMPLAINT SUMMARY: THE DEVICE WAS RECEIVED, IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, A SYNFRAME INSULATED TABLE CLAMP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE SYNFRAME INSULATED TABLE CLAMP (PART # 387.346, LOT # BAG0722, MFG # 04/27/2017) WAS RECEIVED AT US CQ WITH THE TABLE CLAMP COMPLETELY INTACT. THE BLUE KNOB WAS ABLE TO BE MOVED UP AND DOWN TO ADJUST TO THE CLAMPING ON A TABLE. HOWEVER, THE BLACK KNOB WAS STUCK AND NOT ABLE TO BE MOVED. THIS IS NOT CONSISTENT WITH THE REPORTED COMPLAINT CONDITION; THEREFORE, THE COMPLAINT IS NOT CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS THERE IS NO RELEVANT DIMENSION FOR THE KNOB BEING STUCK. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED; HALTEKLAMMER KPL: SE_112741 REV E. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, A SYNFRAME INSULATED TABLE CLAMP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354920 SYNFRAME INSULATED TABLE CLAMP MISC ORTHO SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 387.346 BAG0722 10705034771120

    Patients

    Seq Age Sex Outcome Treatment
    1