BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER F/EXTRACT

    MDR report key: 2883923 · Received December 21, 2012

    Report

    Report Number
    1719045-2012-01437
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 23, 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. THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE HAVE TO ASSUME, THAT FAR TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING REMOVAL AND HAS LED TO THIS BREAKAGE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED TELEFLEX (PRESENTLY (B)(4)) MANUFACTURED THE INNER-SHAFT, FOR THE EXTRACTION SCREWDRIVER, P/N 03.613.004, LOT # 6180154 (SUPPLIER LOT NUMBER 608346E09). TELEFLEXS CERTIFICATES OF COMPLIANCE SPECIFIES THE INNER-SHAFT FOR THE EXTRACTION SCREWDRIVER CONFORMED TO THE CORRECT SPECIFICATION AND MET ALL REQUIREMENTS. THE LOT WAS MANUFACTURED TO THE SYNTHES DRAWING. THE SYNTHES INCOMING FINAL INSPECTION SHEET INDICATES THE LOT WAS INSPECTED AND CONFORMED TO ALL REQUIRED SPECIFICATIONS. THERE WERE NO MRRS, NCRS, OR ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE SCREWDRIVER BROKE DURING SCREW REMOVAL. THE HOSPITAL DISPOSED THE BROKEN FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER F/EXTRACT SCREWDRIVER HXX SYNTHES MONUMENT 608346E09

    Patients

    Seq Age Sex Outcome Treatment
    1