BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-RT

    MDR report key: 3082673 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11085
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE SHAFT OF THE COUPLING BOLT IS BROKEN. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DISCREPANCY WAS FOUND. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THIS CLEARLY VISIBLE THAT THE SHAFT WAS TWISTED BEFORE IS BROKE. THIS AND THE STRESS MARKS AT THE CONTACT SURFACE ARE AN INDICATION THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO DISTAL FEMUR ORIF PROCEDURE, ON BACK TABLE, AIMING ARM BOLT SHEARED OFF WHEN TIGHTENING TO THE PLATE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185860 PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-RT FZX SYNTHES GMBH 1808762

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR