BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRONAIL TITANIUM TIBIAL NAIL D.8 MM-L.305 MM

    MDR report key: 15273713 · Received August 23, 2022

    Report

    Report Number
    9680825-2022-00018
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 19, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. UNFORTUNATELY ALSO THE LOT NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS DEVICE BATCH NUMBER, DATE OF THE NAIL IMPLANTATION, DATE THE SURGEON WAS MADE AWARE OF THE PATIENT PROBLEM (METALLOSIS), DATE OF THE DEVICE REMOVAL, INFORMATION ABOUT ANY HISTORY OF METAL SENSITIVITY IN THIS PATIENT, NAME OF ANY CLEANING FLUIDS WHICH WERE USED TO CLEAN THIS DEVICE (BEFORE USE ON PATIENT AND INTRAOPERATIVELY AND ON THE SKIN) AND THE DEVICE AVAILABILITY FOR THE TECHNICAL EVALUATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE T748305 BATCH 06/17377 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2007, WAS COMPRISED OF 24 UNITS, ASSEMBLED IN SEVERAL LOT OF FINISHED DEVICE CODE 99-T748305. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. TECHNICAL EVALUATION A TECHNICAL EVALUATION OF THE DEVICE CONCERNED WAS NOT POSSIBLE AS THE DEVICE WAS NOT RETURNED TO ORTHOFIX. THE TECHNICAL EVALUATION WILL BE PERFORMED SHOULD THE DEVICE BECOME AVAILABLE. MEDICAL EVALUATION A MEDICAL EVALUATION OF THE EVENT WAS NOT PERFORMED AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. CONCLUSION A TECHNICAL EVALUATION OF THE DEVICE CONCERNED WAS NOT POSSIBLE AS THE DEVICE WAS NOT RETURNED TO ORTHOFIX SRL. THE TECHNICAL EVALUATION WILL BE PERFORMED SHOULD THE DEVICE BECOME AVAILABLE. A MEDICAL EVALUATION OF THE EVENT WAS NOT PERFORMED AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. CONSIDERING THE FEW AND DISCORDANT INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO CONDUCT ANY INVESTIGATION AND THEREFORE TO DRAW ANY CONCLUSION IN REGARDS TO THE COMPLAINED METALLOSIS. SHOULD FURTHER INFORMATION AND/OR THE DEVICE CONCERNED BECOME AVAILABLE, ORTHOFIX SRL WILL PROMPTLY RE-OPEN THE INVESTIGATION ON THE CASE. ORTHOFIX SRL WOULD LIKE TO UNDERLINE THAT THE BATCH NUMBER COMMUNICATED (06/17377) WAS MANUFACTURED IN 2007 AND RELEASED TO THE MARKET AT THAT TIME IN SEVERAL BATCHES OF FINISHED STERILE PRODUCT, CODE 99-T748305. ALL THESE BATCHES WERE ALREADY EXPIRED AT THE TIME OF USE FOR THIS SPECIFIC CASE (DECEMBER 29, 2020). IT IS THEREFORE MOST LIKELY THAT THIS DEVICE WAS REPROCESSED AND RE-STERILIZED BY THE USER. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-T748305. EVENT DESCRIPTION: "I HAVE RECEIVED A COMPLAINT INVOLVING METALLOSE. BUT IN THIS CASE, THE SURGEON DR. (B)(6) DIDN'T HAVE ANY PICTURE OR X-RAY AS EVIDENCE OF THE CASE". MANUFACTURER REF: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-T748305. EVENT DESCRIPTION: "I HAVE RECEIVED A COMPLAINT INVOLVING METALLOSE. BUT IN THIS CASE, THE SURGEON DR. MARINA JULIANA FIGUEIREDO DIDN'T HAVE ANY PICTURE OR X-RAY AS EVIDENCE OF THE CASE". ON OCTOBER 17, 2022, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: BATCH NUMBER OF THE DEVICE: 06/17377. HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: LOWER LIMB (TIBIA). SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 17 YEARS, MALE, 55 KG. PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL. DATE OF DEVICE REMOVAL: (B)(6) 2022. EVENT DESCRIPTION: ACCORDING TO MARINA'S DOCTOR, SHE SUSPECTED METALLOSE DURING THE REMOVAL/EXTRACTION PROCESS. SHE DIDN'T GIVE ANY ADDITIONAL INFORMATION, THERE IS NOT ANY PICTURE BEFORE NAIL REMOVAL OR WAS PROVIDED PATHOLOGICAL TESTING. THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. PATIENT HEALTH STATUS IS GOOD AND STABLE. THE DEVICE WILL NOT BE RETURNED. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344991 CENTRONAIL TITANIUM TIBIAL NAIL D.8 MM-L.305 MM CENTRONAIL TITANIUM TIBIAL NAIL D.8 MM-L.305 MM HSB ORTHOFIX SRL 99-T748305 06/17377

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Required Intervention