BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER-HEX LRG Ø3.5 W/GROOVE L240

    MDR report key: 3031438 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01330
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES GMBH
    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

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DHR REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WE HAVE FORWARDED THE COMPLAINED SCREWDRIVER TO THE RESPONSIBLE DEPARTMENT FOR EVALUATION. THE INVESTIGATION SHOWS NO FATIGUE OF THE MATERIAL. THE EXTERNAL CALIBRATION REPORT SHOWS A TOO LONG RECOVERY TIME AT THE HOLDING PHASE STEAM STERILIZATION. A POSSIBLE REASON COULD BE A LOOSE CONNECTION TO THE MEASURING SENSOR WITH THE INSTRUMENT, A DEFECTIVE THERMOCOUPLE, OR LACK OF THE STERILIZER. THE HANDLE MATERIAL WE USE SINCE A LONG TIME AND WE DO NOT GET ANY COMPLAINT BY THE MARKET. THE MEASURABLE DIMENSIONS OF THE DEFORMED INSTRUMENT WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THIS ITEM DID NOT PASS THE VALIDATION OF STERILIZATION, DUE TO TEMPERATURE AND TIME. A REPRESENTATIVE FROM (B)(6) CLAIMS THAT THIS OFTEN HAPPENS WHEN THIS TYPE OF DEVICE IS WORN OUT.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134265 SCRDRIVER-HEX LRG Ø3.5 W/GROOVE L240 HXX SYNTHES GMBH 2667518

    Patients

    Seq Age Sex Outcome Treatment
    1