BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES

    MDR report key: 3023090 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-10643
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    August 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND RUSTY DISCOLORATIONS WERE OBSERVED ALL OVER THE INSTRUMENT. SYNTHES INSTRUMENTS ARE MADE PREDOMINANTLY FROM CORROSION-RESISTANT STEELS. AS A RESULT OF THEIR HIGH CHROMIUM AND NICKEL CONTENT, CORROSION-RESISTANT STEELS FORM A PROTECTIVE CHROMIUM OXIDE LAYER, KNOWN AS A PASSIVE LAYER, ON THE METAL SURFACE. THIS PASSIVE LAYER PROTECTS THE INSTRUMENT AGAINST CORROSION AND RUST. THERE ARE DIFFERENT REASONS WHICH CAN DAMAGE THIS LAYER AND LEAD TO CORROSION: THE USE OF EXTRA FINE OR NORMAL STEEL WOOL, STEEL BRUSHES, FILES OR OTHER CLEANING TOOLS WITH ABRASIVE EFFECT ON METALS TO CLEAN SURGICAL INSTRUMENTS, AS THIS WILL RESULT IN MECHANICAL DAMAGE TO THE PASSIVE LAYER; EXCESSIVE CONCENTRATIONS OF DETERGENTS, DISINFECTANTS, RINSING AIDS AND OTHER ADDITIVES OR STRONGLY ACIDIC OR ALKALINE DETERGENTS CAN ATTACK THE PROTECTIVE OXIDE LAYER OF (B)(4); MOST HUMAN BODY FLUIDS AND RESIDUES CONTAIN CHLORINE IONS, WHICH CAN LEAD TO CORROSION IF LEFT TO ADHERE TO, OR DRY ON, THE INSTRUMENT FOR PROLONGED PERIODS; IF (B)(4) INSTRUMENTS ARE LEFT IN CONTACT FOR LONG PERIODS WITH SURFACE-DAMAGED INSTRUMENTS AND ARE SIMULTANEOUSLY MOISTENED WITH AN ELECTROLYTE, RUST CAN FORM AT THE POINTS OF CONTACT; MOVING INSTRUMENT PARTS, E.G. JOINTS, SLIDING PARTS, DISMANTABLE THREADED CONNECTIONS, ETC. MUST BE REGULARLY LUBRICATED. CONSTANT METALLIC ABRASION INCREASES THE DAMAGE TO THE PASSIVE LAYER AND THUS GREATLY INCREASES THE RISK OF CORROSION; CLOTHS USED TO PACK THE DEVICES MUST BE FREE OF DETERGENT OR OTHER RESIDUES. SUCH RESIDUES CAN BE TRANSFERRED TO THE DEVICE SURFACE VIA STEAM AND CAN INTERACT WITH THE SURFACE. BASED ON THE MULTIPLE POSSIBLE POST-MANUFACTURING REASONS FOR CORROSION AND THE AGE OF THE INSTRUMENTS, WE EXCLUDE A MANUFACTURING FAULT. THIS COMPLAINT IS INVALID.

    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. LOT NUMBER PROVIDED HAS NOT BEEN VERIFIED. MANUFACTURING EVALUATION REVEALED THAT THE RETURNED BENDING IRONS WERE VERY DISCOLORED. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION, THE COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    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.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE RUSTING INSTRUMENTS IN THE TRAYS. THE FACILITY HAS HAD THESE SPECIFIC TRAYS FOR ABOUT 7-8 YEARS. THE INSTRUMENTS ARE IN QUARANTINE AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT NOTED. THIS IS REPORT 4 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126955 BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES KWP SYNTHES GMBH 2033467

    Patients

    Seq Age Sex Outcome Treatment
    1