BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL

    MDR report key: 3800440 · Received May 8, 2014

    Report

    Report Number
    1719045-2014-10186
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6) MEDICAL PRODUCTS INC. MANUFACTURED THE CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL, P/N 03.505.205, AND LOT NUMBER 7363346 FOR PO (B)(4). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.505.205, REVISION ¿D¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION ¿E¿ THERE WERE NO NON-CONFORMANCE REPORTS GENERATED FOR THIS LOT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS PERFORMED. THE TIP IS BROKEN. THE ARTICLES WHERE ANALYZED 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. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. IT APPEARS THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. NO PRODUCT FAULT COULD BE DETECTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PRODUCT WAS RECEIVED WITH A BROKEN TIP THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277679 CRUCIFORM SCREWDRIVER BLADE HEX COUPLING/SMALL SCREWDRIVERS HXX SYNTHES MONUMENT 7363346

    Patients

    Seq Age Sex Outcome Treatment
    1