BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITT SAW-ATTACHM F/TRS

    MDR report key: 4143476 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01359
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE DID NOT FUNCTION PROPERLY. THIS WAS CONTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 04/29/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYNTHES TRX MOTOR (FROM ORTHOPEDICS) HAS A FAILURE IN THE OSCILLATING SAW USE. ACCORDING TO THE SURGEON, THE MOTOR MAKES A STRANGE NOISE AND THE SAW BLADE SHOWS LAXITY DURING USE WHICH AFFECTS THE CUTTING PRECISION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622327 SAGITT SAW-ATTACHM F/TRS HWE SYNTHES GMBH 2602

    Patients

    Seq Age Sex Outcome Treatment
    1