BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS

    MDR report key: 3082402 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11058
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 29, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLACEHOLDER.

    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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE INSTRUMENT EXHIBITED VERY SLIGHT DISCOLORATION. THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. MICROSCOPIC EXAMINATION SHOWED THAT THE DISCOLORATION WAS CAUSED BY AN UNKNOWN SUBSTANCE THAT HAS DRIED ON THE INSTRUMENT. REGARDING GENERAL CORROSION IT CAN BE STATED THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL AS WELL, ARE ONLY CONDITIONALLY RUST-RESISTANT. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    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. (B)(6). ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAPHICS CASE BECAME DISCOLORED AND SOME INSTRUMENTS NOW SHOW RUST SPOTS AFTER WASH AND STERILIZATION. IT WAS REPORTED THAT THE BLACK LETTERS BECAME DARK PURPLE. THE BROKEN SCREW REMOVAL SET WAS PURCHASED AND AFTER FIRST OR SECOND WASH AND STERILIZATION, THE INTERNAL COMPONENTS OF THE GRAPHICS CASE BECAME DISCOLORED WITH A STRONG ELECTRICAL BURNING ODOR. SEVERAL INSTRUMENTS ALSO BECAME SPOTTED WITH RUST. SET WAS IN THE BLUE KIMGUARD WRAP WITH A TOWEL UNDER AND ATOP THE SET. SET WAS WASHED WITH A NEUTRAL DETERGENT AND RAN AT 270 DEGREES FOR 10 MINUTE EXPOSURE WITH A 60 MINUTE DRY ON SFPP (STEAM FLUSH PRESSURE PULSE) THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184076 EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS HWB SYNTHES GMBH 7800783

    Patients

    Seq Age Sex Outcome Treatment
    1