BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14.5MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

    MDR report key: 3233662 · Received July 18, 2013

    Report

    Report Number
    1719045-2013-01794
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. (B)(4) MANUFACTURED THE 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE, P/N (B)(4), AND LOT NUMBER 7069802. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: C & J INDUSTRIES MANUFACTURED THE 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE, P/N 03.010.438S, AND LOT NUMBER 7069802. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED DECEMBER 6, 2012) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.010.438S, REVISION C AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), REVISION C (DATED JANUARY 9, 2013). NCR (B)(4) (WRITTEN JANUARY 9, 2013) WAS FOR THE INCORRECT PART NUMBER DOCUMENTED ON THE CERTIFICATE OF CONFORMANCE. THE CERT WAS CHANGED AND RETURNED TO SYNTHES, AND THE NCR WAS CLOSED FEBRUARY 25, 2013. HOWEVER, IT HAS SINCE BEEN DETERMINED THAT THE INCORRECT PARTS WERE SHIPPED TO SYNTHES. THE SUPPLIER PROVIDED 03.010.437S 12.0 MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE IN LIEU OF 03.010.438S. STOCK HOLD/STOCK EVAL #(B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. THEREFORE, THIS IS A VALID COMPLAINT FROM A MANUFACTURING POSITION. THIS WASN'T CAUGHT AT INCOMING INSPECTION DUE TO THE PART BEING STERILE AND NEEDING TO PERFORM DESTRUCTIVE TESTING IN ORDER TO INSPECT THIS FEATURE.

    Description of Event or Problem · 1

    PRIOR TO THE PATIENT BEING BROUGHT TO THE OR FOR A TIBIAL NAILING PROCEDURE THE SCRUB TECH OPENED A DISPOSABLE 14.5MM SUPRA PATELLAR OUTER PROTECTION SLEEVE AND NOTED THE PACKAGE CONTAINED A 12MM PROTECTION SLEEVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECT TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333340 14.5MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE JDS SYNTHES MONUMENT 7069802

    Patients

    Seq Age Sex Outcome Treatment
    1