BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD HOLDER

    MDR report key: 3074675 · Received April 24, 2013

    Report

    Report Number
    1719045-2013-01287
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Report Date
    March 25, 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

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INSTRUMED MANUFACTURED THE ROD INTRODUCER. DUE TO A CRACK, CAUSE UNKNOWN, IN THE TIP OF THE INSTRUMENT IT HAS BECOME UNUSABLE. THE MATERIAL AND DIMENSIONS ARE TO SPECIFICATION. DUE TO THE BROKEN TIP FUNCTIONALITY COULD NOT BE TESTED. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 6675347, 5 PARTS, REVEALED THAT INSTRUMEDICAL TECHNOLOGIES MANUFACTURED THE ROD INTRODUCER. THE PARTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION AND THE PARTS CONFORMED TO ALL REQUIREMENTS AND THE CERTIFICATE OF COMPLIANCE WAS DATED 8/30/2011. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE LATERAL WALL ON THE TIP IS CRACKED AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO COMPLAINT RELATED ANOMALIES WERE IDENTIFIED. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE; WE CAN ONLY ASSUME THAT TOO HIGH APPLIED FORCES DURING THE ROD INTRODUCTION CAUSED THIS DAMAGE. NEVERTHELESS, WE WILL FORWARD THIS DEVICE TO THE MANUFACTURING PLANT FOR FURTHER DETAILED INVESTIGATION. THE INVESTIGATION IS ONGOING.

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING NORMAL USE ON AN UNKNOWN DATE, THE TIP OF A ROD HOLDER CRACKED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177484 ROD HOLDER LXH SYNTHES MONUMENT 6675347

    Patients

    Seq Age Sex Outcome Treatment
    1