BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLECRANON PLATE VARIAX FOR RIGHT ULNA 6 HOLE / L113MM

    MDR report key: 3141355 · Received June 3, 2013

    Report

    Report Number
    0008031020-2013-00171
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    August 30, 2012
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K101056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE WHOLE CASE WAS SENT TO OUR MEDICAL EXPERT AND HE STATED: ¿THE INFECTION OF A DISK IS A NORMAL COMPLICATION (INCIDENCE APPROXIMATELY 2% - 5%), WHICH IS EITHER FATE OR IS CAUSED BY LACK OF HYGIENE DURING SURGERY OR POST-OPERATIVE CARE. STRYKER HAS NOTHING TO DO WITH THIS EVENT. YOU CAN CLOSE THE CASE WITHOUT FURTHER ACTION.¿ [ORIGINAL STATEMENT] A SIMILAR STATEMENT WAS TAKEN FROM THE OR NURSING RECORD (B)(4) ON PAGE 8 OF 14: ¿PRE-CARE TEXT: PLAN OF CARE: POTENTIAL PROBLEM(S) POTENTIAL FOR INFECTION RELATED TO IMPROPER STERILIZATION OR HANDLING OF IMPLANTS.¿ [ORIGINAL STATEMENT] WE ASSUME THAT THE COMPLICATIONS WERE NOT ATTRIBUTED TO THE STRYKER PLATE, BECAUSE THE REPORTED PLATE WAS A NON-STERILE PRODUCT AND THEREFORE THE HOSPITAL IS RESPONSIBLE TO BE SURE THAT THE PRODUCT IS STERILE BEFORE IMPLANTATION. THE IFU FOR NON-ACTIVE IMPLANT (B)(4) WAS REVIEWED: " .... IN THE EVENT OF CONTAMINATION (UNLESS CONTAMINATED WITH BODY FLUIDS), OR EXPIRATION OF SHELF LIFE OR IN THE CASE OF PRODUCTS SUPPLIED NON-STERILE, THE PRODUCT MUST BE SUBJECTED TO AN APPROPRIATE CLEANING PROCESS AND STERILIZED BY MEANS OF A VALIDATED STERILIZATION PROCEDURE BEFORE USE, UNLESS SPECIFIED OTHERWISE IN THE PRODUCT LABELING OR RESPECTIVE PRODUCT TECHNICAL GUIDES. THE FOLLOWING PROCESS PARAMETERS ARE VALIDATED BY STRYKER AND RECOMMENDED FOR STERILIZATION AND/OR RESTERILIZATION: METHOD (US): MOIST-HEAT STERILIZATION CYCLE: PRE-VACUUM (PRE-VAC) TEMPERATURE: 270° F (132° C) EXPOSURE TIME: 4 MINUTES PRESSURE: 2-15 PSIA DRY-TIME: 30 MINUTES (MINIMUM, IN CHAMBER) COOL-TIME: 60 MINUTES (MINIMUM, AT ROOM TEMPERATURE) METHOD (O/US): MOIST HEAT STERILIZATION ACCORDING TO EN ISO (B)(4) CYCLE: SATURATED STEAM WITH FORCED AIR REMOVAL EXPOSURE PHASE AND 4 TO 18 MINUTES AND DRYING DRYING TIME: BETWEEN 8 AND 35 MINUTES TEMPERATURE: 132 - 137°C (270 - 277°F) NOTE: NOT FOR PRION INACTIVATION NOTE: ANY CYCLE SHOULD BE VALIDATED FOR DIFFERENT STERILIZATION CHAMBERS, WRAPPING METHODS AND/OR VARIOUS LOAD CONFIGURATIONS. FOR FURTHER INFORMATION, PLEASE REFER TO THE INSTRUCTION FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE OF STRYKER OSTEOSYNTHESIS MEDICAL DEVICES." [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE WHOLE CASE WAS SENT TO OUR MEDICAL EXPERT AND HE STATED: ¿THE INFECTION OF A DISK IS A NORMAL COMPLICATION (INCIDENCE APPROXIMATELY 2% - 5%), WHICH IS EITHER FATE OR IS CAUSED BY LACK OF HYGIENE DURING SURGERY OR POST-OPERATIVE CARE. STRYKER HAS NOTHING TO DO WITH THIS EVENT. YOU CAN CLOSE THE CASE WITHOUT FURTHER ACTION.¿ [ORIGINAL STATEMENT] A SIMILAR STATEMENT WAS TAKEN FROM THE OR NURSING RECORD ICVRH ON PAGE 8 OF 14: ¿PRE-CARE TEXT: PLAN OF CARE: POTENTIAL PROBLEM(S) POTENTIAL FOR INFECTION RELATED TO IMPROPER STERILIZATION OR HANDLING OF IMPLANTS.¿ [ORIGINAL STATEMENT] WE ASSUME THAT THE COMPLICATIONS WERE NOT ATTRIBUTED TO THE STRYKER PLATE, BECAUSE THE REPORTED PLATE WAS A NON-STERILE PRODUCT AND THEREFORE THE HOSPITAL IS RESPONSIBLE TO BE SURE THAT THE PRODUCT IS STERILE BEFORE IMPLANTATION. THE IFU FOR NON-ACTIVE IMPLANT V15013/J WAS REVIEWED: " ....IN THE EVENT OF CONTAMINATION (UNLESS CONTAMINATED WITH BODY FLUIDS), OR EXPIRATION OF SHELF LIFE OR IN THE CASE OF PRODUCTS SUPPLIED NON-STERILE, THE PRODUCT MUST BE SUBJECTED TO AN APPROPRIATE CLEANING PROCESS AND STERILIZED BY MEANS OF A VALIDATED STERILIZATION PROCEDURE BEFORE USE, UNLESS SPECIFIED OTHERWISE IN THE PRODUCT LABELING OR RESPECTIVE PRODUCT TECHNICAL GUIDES. THE FOLLOWING PROCESS PARAMETERS ARE VALIDATED BY STRYKER AND RECOMMENDED FOR STERILIZATION AND/OR RESTERILIZATION: METHOD (US): MOIST-HEAT STERILIZATION CYCLE: PRE-VACUUM (PRE-VAC) TEMPERATURE: 270° F (132° C) EXPOSURE TIME: 4 MINUTES PRESSURE: 2-15 PSIA DRY-TIME: 30 MINUTES (MINIMUM, IN CHAMBER) COOL-TIME: 60 MINUTES (MINIMUM, AT ROOM TEMPERATURE) METHOD (O/US): MOIST HEAT STERILIZATION ACCORDING TO EN ISO 17665-1 CYCLE: SATURATED STEAM WITH FORCED AIR REMOVAL EXPOSURE PHASE AND 4 TO 18 MINUTES AND DRYING TIME: BETWEEN 8 AND 35 MINUTES TEMPERATURE: 132 - 137°C (270 - 277°F) NOTE: NOT FOR PRION INACTIVATION NOTE: ANY CYCLE SHOULD BE VALIDATED FOR DIFFERENT STERILIZATION CHAMBERS, WRAPPING METHODS AND/OR VARIOUS LOAD CONFIGURATIONS. FOR FURTHER INFORMATION, PLEASE REFER TO THE INSTRUCTION FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE OF STRYKER OSTEOSYNTHESIS MEDICAL DEVICES." [ORIGINAL STATEMENT] A REVIEW A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN THE RIGHT ARM AND DOES NOT HAVE USE OF IT. AT THE END OF (B)(6) 2012, THE PATIENT HAD PUSS DRAINING FROM HER ARM OUT OF TWO HOLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN THE RIGHT ARM AND DOES NOT HAVE USE OF IT. AT THE END OF (B)(6) 2012 THE PATIENT HAD PUSS DRAINING FROM HER ARM OUT OF TWO HOLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN THE RIGHT ARM AND DOES NOT HAVE USE OF IT. AT THE END OF (B)(6) 2012 THE PATIENT HAD PUSS DRAINING FROM HER ARM OUT OF TWO HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244532 OLECRANON PLATE VARIAX FOR RIGHT ULNA 6 HOLE / L113MM IMPLANT HRS STRYKER TRAUMA SELZACH X23205

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization