BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE

    MDR report key: 11801121 · Received May 10, 2021

    Report

    Report Number
    8030965-2021-03756
    Event Type
    Injury
    Date Received
    May 10, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819835146
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: STERILE-PART: PART: 04.013.752S, LOT: 9751378, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 02. DEC. 2015, EXPIRY DATE: 01. NOV. 2025. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY DHR REVIEW IS DONE FOR NON-STERILE PART: NON-STERILE-PART: PART: 04.013.752, LOT: 9902611, MANUFACTURING SITE: (B)(4), MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 17-SEP-2015, PART NUMBER: 04.013.752, 13MMTI CANN RETRO/ANTEGRADE FEMORAL NAIL ¿ EX/360MM, LOT NUMBER: 9902611 (NON-STERILE), LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INPROCESS / INSPECT DIMENSIONAL / FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 21014, TIALNBRI16.00, LOT NUMBER: 7777885, LOT QUANTITY: (B)(4). CERTIFICATE OF REPORT WAS REVIEWED AND FOND TO BE CONFORMING. LOT SUMMARY REPORT DATED 20-AUG-2014 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/ PUTAWAY CHECKLIST METAL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY WITH NAILS TO TREAT BOTH FEMORAL DIAPHYSIS FOR PREVENTION OF ATYPICAL FRACTURES. ANTEGRADE INSERTION WAS PERFORMED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ON UNKNOWN DATE, THE PATIENT HAD FEMORAL NECK FRACTURE IN BOTH LEGS. ON (B)(6) 2019, THE RIGHT LEG WAS REPLACED WITH A DUAL HOOK. ON (B)(6) 2021, THE LEFT LEG IS SCHEDULED TO BE REPLACED WITH A DUAL HOOK AFTER THE NAIL REMOVAL. THE SURGEON STATED THAT THE CAUSE OF THIS EVENT MIGHT BE BONE FRAGILITY ASSOCIATED WITH OSTEOPOROSIS IN THE PATIENT AND STRESS OF THE IMPLANT CONCENTRATED IN THE FEMORAL NECKS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697123 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 9751378 07611819835146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention