BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3096680 · Received May 7, 2013

    Report

    Report Number
    8030965-2013-02125
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED BY THE PRODUCT DEVELOPMENT ENGINEER AND IT WAS REPORTED: THE RETURNED AIMING ARM (PART#03.010.052, LOT#1810651) WAS MANUFACTURED IN MARCH 2008 AND IS OVER 5 YEARS OLD. THE RETURNED STANDARD INSERTION HANDLE (PART#03.010.045, LOT#1788318) WAS MANUFACTURED IN JANUARY 2008 AND IS OVER 5 YEARS OLD. DURING THIS EVALUATION, THE RETURNED DEVICES WERE ASSEMBLED IN ATTEMPT TO RECREATE THE COMPLAINT CONDITION. THE RETURNED AIMING ARM AND INSERTION HANDLE ALIGNED AND ASSEMBLED TOGETHER WITH NO ISSUE DURING THIS EVALUATION. THE COMPLAINT REGARDING THE SMALL PEGS NOT CONNECTING PROPERLY COULD NOT BE REPLICATED AS THEY SHOW NO SIGNS OF DAMAGE, AND ALIGNED AS INTENDED WITH THE INSERTION HANDLE AND THE THUMB SCREW WAS ABLE TO SECURE THE DEVICES TOGETHER WITH NO ISSUE. THERE ARE 2 COMPLAINTS FOR AIMING ARM PART# 03.010.052 WITH THE COMPLAINT CONDITION OF "BENT" IN THE ENTIRE COMPLAINT HISTORY AND APPROXIMATELY 1,564 HAVE BEEN DISTRIBUTED SINCE 2006 (OLDEST SALES DATA AVAILABLE IN JDE) WHICH RESULTS IN AN ESTIMATED COMPLAINT RATE OF 0.13% BASED ON SALES. THIS AIMING ARM IS USED IN MULTIPLE SYSTEMS AND USED REPEATEDLY SO THE ACTUAL COMPLAINT RATE BASED ON USAGE WOULD BE SIGNIFICANTLY LOWER. THERE ARE 11 COMPLAINTS FOR STANDARD INSERTION HANDLE PART# 03.010.045 WITH THE COMPLAINT CONDITION OF "BENT" IN THE ENTIRE COMPLAINT HISTORY AND APPROXIMATELY 3,557 HAVE BEEN DISTRIBUTED SINCE 2006 (OLDEST SALES DATA AVAILABLE IN JDE) WHICH RESULTS IN AN ESTIMATED COMPLAINT RATE OF 0.3% BASED ON SALES. THIS INSERTION HANDLE IS USED IN MULTIPLE SYSTEMS AND USED REPEATEDLY SO THE ACTUAL COMPLAINT RATE BASED ON USAGE WOULD BE SIGNIFICANTLY LOWER. THE SUPRAPATELLAR INSERTION INSTRUMENTS RISK ANALYSIS (DOCUMENT#0000021157, VERSION A.18) ADEQUATELY ASSESSES THIS COMPLAINT CONDITION. SPECIFICALLY, LINE# 2010 ASSESSES THE RISK ASSOCIATED WITH AN INSTRUMENT BENDING DUE TO "EXCESSIVE LOAD, MISUSE OR DESIGNED TO INSUFFICIENT SIZE OR STRENGTH" AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM "3" AND AN UNLIKELY PROBABILITY OF OCCURRENCE "2" WITH POSSIBLE HARM LISTED AS "INJURY TO PATIENT OR USER (E.G. SOFT TISSUE IRRITATION), SIGNIFICANT ELONGATION OF OR TIME (>20%), USE OF AN ALTERNATIVE PRODUCT (OTHER SYSTEM, AVAILABLE IN THE HOSPITAL)". THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USES AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. IN CONCLUSION, THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USES AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION THEREFORE THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    DURING AN IM TIBIA NAILING PROCEDURE ON (B)(6) 2013, MISALIGNMENT OCCURRED TO THE INSTRUMENT DUE TO THE AIMING ARM NOT BEING CONNECTED CORRECTLY TO THE INSERTION HANDLE VIA THE SMALL PEGS THAT ARE PART OF THE DEVICE. THIS MISALIGNMENT CAUSED THE DRILL BIT TO HIT THE EX TIBIA NAIL. THE INSERTION HANDLE AND TARGETING GUIDE APPEARED BENT. THIS CAUSED THE SURGERY TO BE DELAYED BY APPROXIMATELY 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199512 STANDARD INSERTION HANDLE FZX SYNTHES GMBH 1788318

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention