BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER T25 LONG W/T-HANDLE F/MATRIX

    MDR report key: 2923312 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00157
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY RECORDS WERE REVIEW AND SUBJECT INSTRUMENT PASSED ALL INSPECTION CRITERIA AND CERTIFICATION TESTING. THERE WERE NO NON CONFORMANCE DOCUMENTS ISSUED DURING MANUFACTURING. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL SPECIFICATION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. WE CAN ONLY ASSUME THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. THE VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHAT INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE SCREWDRIVER BROKE DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31205 SCRDRIVER T25 LONG W/T-HANDLE F/MATRIX SCREWDRIVER HXX SYNTHES MONUMENT 6631153

    Patients

    Seq Age Sex Outcome Treatment
    1