BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHN MULTILOC 8 IZQ CAN L160 TAN

    MDR report key: 12703522 · Received October 27, 2021

    Report

    Report Number
    8030965-2021-09023
    Event Type
    Injury
    Date Received
    October 27, 2021
    Report Date
    September 30, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819431034
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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 HISTORY LOT: PRODUCT CODE: 04.016.035S; LOT NUMBER: 37P5301; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 18 MAR 2020; EXPIRY DATE: 01 MAR 2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2021, THE PATIENT UNDERWENT THE SURGERY FOR THE PROXIMAL END OF HUMERUS FRACTURE WITH THE MULTILOC PROXIMAL HUMERAL NAIL IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE BONE HEAD CUT-OUT WAS CONFIRMED. THE SURGEON SUSPECTED THE CAUSE OF THE EVENT WAS A FALL, BUT THERE WAS NO EVIDENCE. THE SURGEON ALSO REDUCED THE INVAGINATION AFTER PROXIMAL FIXATION, AND THUS, DID NOT KNOW ANY OTHER CAUSE OF THE EVENT. SINCE THE PATIENT IS UNDER MEDICAL TREATMENT FOR ANOTHER DISEASE DEPARTMENT, THE SURGEON WILL CONSIDER ABOUT THE TREATMENT FOR THE PROXIMAL END OF HUMERUS AFTER THE TREATMENT. IT IS UNKNOWN IF REVISION SURGERY WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PHN MULTILOC Ø8 IZQ CAN L160 TAN. THIS IS REPORT 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602252 PHN MULTILOC 8 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 37P5301 07611819431034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI| LOCKSCR Ø3.5 SELF-TAP L34 TAN| LOCKSCR Ø4 L26 F/NAILS TAN DBLUE| LOCKSCR Ø4 L26 F/NAILS TAN DBLUE| TORNILLO MULTILOC Ø4.5 L32 TAN| TORNILLO MULTILOC Ø4.5 L32 TAN| TORNILLO MULTILOC Ø4.5 L36 TAN