BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDING INSERT F/AIMING ARM F/PF

    MDR report key: 2947697 · Received February 7, 2013

    Report

    Report Number
    2520274-2013-00810
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED AT SYNTHES (B)(4). THE LOCKING SLIDING INSERT LOOSENS CLOCKWISE WHEN INSERTING THE PROTECTION SLEEVE DURING THE ROTATION OF BUTTRESS NUT/COMPRESSION NUT. AS A RESULT, THE MEASUREMENT FOR THE LENGTH OF THE BLADE CAN BE INCORRECTLY DETERMINED WHICH COULD LEAD TO A WRONG SELECTION IN THE LENGTH OF THE BLADE. CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE. THE NEW DESIGN OF THE LOCKING SLIDING INSERT IS CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE LOCKING SLIDING INSERT OF THE AIMING ARM INSTRUMENT. IT WAS REPORTED THAT WHEN TENSION IS APPLIED ON THIS SLIDING INSERT, IT JUMPS OUT OF THE AIMING ARM. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51921 LOCKING SLIDING INSERT F/AIMING ARM F/PF LOCKING SLIDING INSERT LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1