BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX STERILE FIELD POST

    MDR report key: 6115150 · Received November 18, 2016

    Report

    Report Number
    2125289-2016-00013
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Report Date
    October 24, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/21/2016 . THE INVESTIGATION INCLUDED: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID LOT #161 MANUFACTURED ON APRIL 11, 2016, LOT# 164 MANUFACTURED ON JUNE 19, 2016 AND LOT# 167 MANUFACTURED ON OCTOBER 05, 2016 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. ENGINEERING NOTICED THE S.F. CLAMP SUBASSEMBLY (P/N 4088021) WAS NOT FUNCTIONING PROPERLY AS DESIGNED. THE S.F CLAMP SUBASSEMBLY PRIMARILY COMPRISES OF TWO .75 SERRATED CLAMPS (P/N 4044011), WHICH LOCK TOGETHER WHEN THE HANDLE IS PLACED IN THE LOCKED POSITION. IN THE LOCKED POSITION, THE STARBURST TEETH DO FULLY ENGAGE WITH NO VISIBLE GAPS PRESENT AND THE HANDLE DOES NOT ALIGN PARALLEL TO THE FIELD POST. IN THE UNLOCKED POSITION WITH THE APPLICATION OF FORCE ON THE CLAMP¿S HANDLE, THE STARBURST TEETH DO FULLY ENGAGE AS WELL AND THE HANDLE REMAINS UNPARALLELED TO THE POST, YET THE CAM BODY (P/N 4047011) DOES NOT FULLY SIT ON THE BUSHING (P/N 4103011) BETWEEN THE .75 SERRATED CLAMP AND CAM BODY AS IT SHOULD. DYSFUNCTIONAL INTERNAL COMPONENTS WITHIN AND ON THE 4088021 ¿S.F. CLAMP SUBASSEMBLY, .75 X .75 SERRATED¿, DUE TO USER ERROR, IS THE PRIMARY CAUSE FOR THE REPORTED SLIPPAGE/ROTATION DURING SURGERY. THERE¿S A POSSIBILITY THAT THE 4088021 ¿S.F CLAMP SUBASSEMBLY¿ PREMATURELY FAILED DUE TO INITIAL GALLING WHICH COULD OF OCCURRED DURING OUR INTERNAL ASSEMBLY PROCESS, CAUSING LOSS OF FUNCTIONALITY AS EXTENSIVE GALLING/WEAR IS ENHANCED AS THE HANDLE IS EXERCISED OVER TIME. PER THE INSTRUCTIONS FOR USE (IFU) THE END USER IS EDUCATED NOT TO FORCE THE HANDLE PAST THE STOP POINT; CAPA HAS BEEN ISSUED TO ADDRESS THE NON-CONFORMANCE ABOVE, AND TO HELP ADOPT MEASURES TO HELP PREVENT ANY FUTURE REOCCURRENCES.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS WE CURRENTLY HAVE TWO EACH IN FOR EVALUATION. POST IS ROTATING/ SLIPPING DURING SURGERY. OPENED 2 TRAYS THAT WERE BOTH NOT LOCKING CORRECTLY: 1 OF 2 RELATED COMPLAINTS FOR SAME PATIENT SAME DAY, ONE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765975 OMNI-FLEX STERILE FIELD POST SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 167

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR