BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD TPLO JIG FOR USE W/ 24MM/27MM/30MM SAW GUIDES

    MDR report key: 3001430 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-10334
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    December 19, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PART WAS RECEIVED DISASSEMBLED AND ONE JIG PIN SCREW WAS NOT RETURNED WITH THE ASSEMBLY. THE END ARM MISSING THE JIG PIN WAS BROKEN WHERE THE JIG PIN SCREW SHOULD HAVE BEEN THREADED, WHICH IS CONSISTENT WITH THE COMPLAINT. DUE TO THE PART BEING BROKEN, NOT ALL RELEVANT FEATURES TO THE COMPLAINT COULD BE CHECKED DURING THE MANUFACTURING EVALUATION. NO ISSUES WERE FOUND DURING THE DIMENSIONAL ANALYSIS ON FEATURES THAT COULD BE CHECKED. SINCE ALL RELEVANT FEATURES COULD NOT BE CHECKED, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED. FROM A DESIGN STANDPOINT, THE MATERIAL SELECTION AND HARDNESS CONDITION WERE ADEQUATE FOR THE ANTICIPATED LOADING. IT IS NOT KNOWN WHAT MIGHT HAVE OCCURRED EITHER DURING MANUFACTURING OR CLINICAL USE THAT RESULTED IN THE FAILURE. FOR THIS REASON, THIS COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT IT SHOULD BE NOTED THAT FOR REASONS RELATED ONLY TO THE INTRA-OPERATIVE FUNCTION OF THE DEVICE, THE DESIGN FOR THIS COMPONENT WAS MODIFIED IN 2010, AFTER THE MANUFACTURE OF THE DEVICE IN QUESTION. WHILE IT IS NOT POSSIBLE TO DETERMINE WHY THIS DEVICE FRACTURED, IT IS LIKELY THAT THE CROSS SECTIONAL AREA DID NOT MEET THE EXPECTED MINIMUM, POSSIBLY DUE TO FEATURE LOCATIONS NOT IDEALIZED OR OF INCORRECT SIZE. THE NEW JIG DESIGN IS SUPERIOR IN ITS RESISTANCE TO THIS STRESS.

    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. ACTUAL EVENT DATE NOT KNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104612 STANDARD TPLO JIG FOR USE W/ 24MM/27MM/30MM SAW GUIDES FZX SYNTHES MONUMENT IS10297

    Patients

    Seq Age Sex Outcome Treatment
    1