BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 2867629 · Received December 11, 2012

    Report

    Report Number
    2520274-2012-03807
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT P101807 REVEALED THE CABLE TENSIONER WAS MANUFACTURED BY PIONEER SURGICAL TECHNOLOGIES. SYNTHES RECEIVED TWO SHIPMENTS OF THIS LOT. (B)(4) WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 9/6/2011. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 9/13/2011.(B)(4) PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION OF THE COMPLAINED CABLE TENSIONER SHOWS THAT THE HOLDING MECHANISM NO LONGER FUNCTIONS AS INTENDED. WE HAVE ANALYZED THE ARTICLE FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) INDICATED: DURING SURGERY FOR ARTIFICIAL HEAD REPLACEMENT, AN ARTIFICIAL BONE WAS BROKEN WHILE INSERTING, SO THAT THE SURGEON USED CABLES. THE FIRST CABLE WAS INSERTED SUCCESSFULLY AND 50 KG WAS APPLIED. SURGEON WENT TO TIGHTEN FURTHER AND THE CABLE TENSIONER BECAME LOOSE. SURGEON FELT NO TENSION AFTER HE TRIED TO TIGHTEN THE CABLE; SURGEON HAD TO TIGHTEN THE CABLE BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE TENSIONER CABLE TENSIONER KTT SYNTHES USA P101807

    Patients

    Seq Age Sex Outcome Treatment
    1