BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS

    MDR report key: 2994299 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00824
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 7, 2013
    Manufacturer
    SYNTHES GMBH
    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

    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT GREASE WAS LEAKING OUT OF THE ARTICLES. TOO MUCH GREASE FILLED IN TO THE ARTICLES. THE SEALING COULD BE DEFECTIVE. WRONG PURIFICATION. THE COMPLAINED PROBLEM IS KNOWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE OIL FLUID LEAKED. THIS REPORT IS #7 OF 7 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS 7 OF 7 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99527 SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS HWE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1