BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5153063 · Received October 15, 2015

    Report

    Report Number
    1719045-2015-10671
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    October 2, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE HAD AN UNKNOWN ISSUE. THE DEVICE WAS SENT TO THE VENDOR FOR FURTHER TESTING. THE ITEM PASSED TESTING AND WORKED WITHIN NORMAL PARAMETERS. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE ITEM WILL BE RETURNED TO THE CUSTOMER. THE EVALUATION WAS 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.

    Additional Manufacturer Narrative · 1

    (B)(6). SERVICE HISTORY REVIEW: PART NO: 391.201, LOT NO: P191072: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 18SEPTEMBER2014. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A CABLE TENSIONER HAD AN UNSPECIFIED MALFUNCTION AND A BENDING PLIERS FOR 2.7MM & 3.5MM PLATES WAS MISSING A BOLT. THIS WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). NO CASE OR PATIENT INVOLVED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684330 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P191072

    Patients

    Seq Age Sex Outcome Treatment
    1