BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING F/DRILL BITS FORTRS

    MDR report key: 2994230 · Received March 8, 2013

    Report

    Report Number
    2520274-2013-01326
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 9, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    WE DETECTED THAT GREASE WAS LEAKING OUT OF THE REFERENCED ARTICLE. POSSIBLE CAUSES: TOO MUCH GREASE FILLED IN TO THE ARTICLES, THE SEALING COULD BE DEFECTIVE, WRONG PURIFICATION.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING DEVICES ASSOCIATED WITH THE TRAUMA RECON SYSTEM. PRIOR TO A PROCEDURE TO TREAT A PATIENT WITH A FRACTURE OF THE SHAFT OF THE LOWER LEG, A NURSE BROKE THE SEAL OF THE STERILIZED PACKAGE AND FOUND NOTICEABLE IMPURITIES, DESCRIBED AS A GRAY-COLOURED OILY SUBSTANCE, ADHERED TO THE SURFACE OF THE TRS DEVICE. THE NURSE WIPED OUT THE IMPURITIES ON THE SURFACE OF THE TRS DEVICE AND THE DOCTOR PROCEEDED TO USE THE DEVICE. THIS IS REPORT NUMBER 2 OF 7 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99292 QUICK COUPLING F/DRILL BITS FORTRS HWE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1