BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION WRENCH Ø11

    MDR report key: 3183169 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03528
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    February 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXC
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE EVALUATION REVEALED THAT THERE ARE SOME RUSTY AREAS MAINLY ON THE CONTACT AREAS WITH SCREW NUTS ON WHICH THE PROTECTIVE COATING HAS WORN OFF DURING LONG TERM USE. THE BASE MATERIAL THEREFORE WAS CHEMICALLY ATTACKED WITH THE RESULT OF PARTIALLY RUST FORMATION; THIS PRODUCT WAS PRODUCED AND DISTRIBUTED IN 1997. PLEASE NOTE: REGARDING CORROSION IT CAN BE STATED, THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL AS WELL, ARE CONDITIONALLY ONLY RUST RESISTANT. THE CORROSION RESISTANCE IS MAINTAINED ONLY, WHEN THE MATERIAL IS STORED ON A DRY AND METALLIC CONTACT LESS CONDITION. ALL METALLIC CONTACTS ON HUMID OR WET CONDITION CREATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. NO PRODUCT OR MATERIAL RELATED FAULT COULD BE DETECTED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRENCH IS CORRODED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL ATTEMPTS REVEALED NO FURTHER INFORMATION IS AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284009 COMBINATION WRENCH Ø11 HXC SYNTHES USA 2064

    Patients

    Seq Age Sex Outcome Treatment
    1