BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3144759 · Received June 4, 2013

    Report

    Report Number
    1719045-2013-01520
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Report Date
    May 8, 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

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES VISUAL INSPECTION CONFIRMED THAT THIS DEVICE DID NOT CONTAIN SUBSTANTIAL DAMAGE THAT COULD HAVE NEGATIVELY AFFECTED THE PERFORMANCE OF THE DEVICE. PART NUMBER 391.201, LOT NUMBER P103168 WAS MANUFACTURED BY PIONEER SURGICAL TECHNOLOGIES. THE SUPPLIER CONDUCTED THE INVESTIGATION ON THE RETURNED PART. THE SUPPLIER CONDUCTED A DEVICE HISTORY RECORD REVIEW WHICH CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING. THE SUPPLIER ALSO TESTED THE TENSIONER AND ALL TEST RESULTS MEET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RELEASED ON 10/17/11, 10/18/11 AND 11/3/11. INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES THE PERFORMED INVESTIGATION HAS CONFIRMED THAT THE CABLE TENSIONER IS STIFF. UNFORTUNATELY THE EXACT CAUSE OF THIS DAMAGE CANNOT BE ELICITED. THE REVIEW OF THE MATERIAL AND MANUFACTURING DOCUMENTS SHOWS NO DEVIATION ACCORDING TO THE SPECIFICATIONS OF THAT TIME. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # P103168 REVEALED THE CABLE TENSIONER WAS MANUFACTURED BY (B)(4). THREE SHIPMENTS WERE RECEIVED BY SYNTHES. PO # 1292537, DATED 10/17/11, FOR (B)(4) PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON 10/18/11. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (COC) IS DATED 10/13/11. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 10/18/11. A SECOND SHIPMENT OF THE SAME PO ARRIVED ON 10/18/11, FOR (B)(4) PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON 10/19/11. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (COC) IS DATED 10/13/11. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 10/19/11. PO #1287822 ARRIVED ON 11/3/11, FOR (B)(4) PART WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON 11/8/11. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (COC) IS DATED 10/24/11. (B)(4) PART WAS RELEASED TO THE WAREHOUSE ON 11/9/11. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION IS ON-GOING. CORRECTED FROM REPORTEDLY THE CABLE TENSIONER IS STILL AND IS PARTLY INTERLOCKING TO REPORTEDLY THE CABLE TENSIONER IS STIFF AND IS PARTLY INTERLOCKING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE CABLE TENSIONER IS STILL AND IS PARTLY INTERLOCKING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY THE CABLE TENSIONER IS STIFF AND IS PARTLY INTERLOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247066 CABLE TENSIONER LXH SYNTHES MONUMENT P103168

    Patients

    Seq Age Sex Outcome Treatment
    1