BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD HOLDER

    MDR report key: 3060973 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-01068
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PART WAS RECEIVED WITH DAMAGE TO THE DISTAL END. THE COMPLAINT ISSUE IS DUE TO AN UNKNOWN CAUSE. INSTRUMED MANUFACTURED THE ROD INTRODUCER, PART NUMBER 03.616.048, LOT NUMBER 6970077. THE SUPPLIER CONDUCTED A DHR REVIEW AND DETERMINED THAT THE PART MET SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE SUPPLIER ALSO REVIEWED THE FUNCTIONAL TESTING AND THE INSTRUMENT CONFORMED TO FUNCTIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING THROUGH FINAL ACCEPTANCE AT INSTRUMED AND AT SYNTHES INCOMING INSPECTION. THE RETURNED PRODUCT DID NOT PASS THE FUNCTIONAL CHECK PER GAGE GT037194. THE COMPLAINT PRODUCT WAS DAMAGED AT THE DISTAL END WHICH IS CONTRIBUTING TO THE COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INSTRUMEDICAL TECHNOLOGIES MANUFACTURED THE ROD INTRODUCER, PART 03.616.048, AND LOT NUMBER 6970077. THE SUPPLIER CERTIFICATE OF COMPLIANCE, DATED (B)(4) 2012, INDICATES THE PARTS WERE MANUFACTURED TO PART 03.616.048, REVISION E AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. THERE WERE NO NON CONFORMITIES OR OTHER COMPLAINT-RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINED ARTICLE WAS SENT TO OUR PRODUCT DEVELOPMENT CENTER. IT WAS DETERMINED THAT THE INSTRUMENT WAS DEFORMED AND CREASED BECAUSE OF EXTERNAL FORCE. DUE TO THIS DAMAGE THE ROD CAN NOT LOCK. A POSSIBLE CAUSE IS THE INFLUENCE OF EXTERNAL FORCES ON THE TIP OF THE ROD DURING THE PROCEDURE OF INSERTING OF THE ROD. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A ROD HOLDER DID NOT FUNCTION. A ROD WOULD NOT LOCK TO THE ROD HOLDER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162899 ROD HOLDER LXH SYNTHES MONUMENT 6970077

    Patients

    Seq Age Sex Outcome Treatment
    1