BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL LARGE TRIAL IMPLANT SIZ 7 NON DETA

    MDR report key: 2914212 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01504
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THE TRIAL IMPLANT WAS MANUFACTURED IN OCTOBER 2011 ACCORDING TO THE SPECIFICATIONS. THE HARDNESS PARAMETERS WERE CHECKED AND REVEALED THAT THE MEASURED HARDNESS IS SLIGHTLY BELOW THE SPECIFICATIONS. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED. THE REPORTED FAILURE METHOD COULD NEITHER BE REPRODUCED WITH HANDLING TESTS NOR MECHANICAL TESTS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTS THE LITTLE BALL AT THE COUPLING PART OF THE TRIAL IMPLANT BROKE OFF DURING REMOVAL. THE BROKEN PART WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-PAL LARGE TRIAL IMPLANT SIZ 7 NON DETA T-PAL LARGE TRIAL IMPLANT SIZ 7 NON DETA HSB SYNTHES GMBH 7599341

    Patients

    Seq Age Sex Outcome Treatment
    1