BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX

    MDR report key: 13763527 · Received March 14, 2022

    Report

    Report Number
    8030965-2022-01610
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 14, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819777415
    PMA / PMN Number
    K040336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PRODUCT CODE #: 04.003.002S. SYNTHES LOT #: 6L71495. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 11FEB2020 EXPIRATION DATE: 01FEB2030. SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART #: 04.003.002 NON-STERILE LOT #: 24P7903 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 15NOV2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON-STERILE ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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 · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SURGERY WITH A FEMORAL RECON NAIL (FRN) FOR THE DIAPHYSEAL FEMUR, AFTER CHECKING THE AP VIEW AND THE ML ANGLE, THE SURGEON INSERTED A END CAP (10MM), BUT THERE WAS A STRANGE NOISE, AND THE END CAP WAS STUCK. SURGEON PULLED OUT THE END CAP AND CONFIRMED THAT THERE WAS A BURR ON THE END CAP THREAD. SURGEON CONFIRMED THAT THE THREAD PART ON THE NAIL SIDE WAS NOT BROKEN. THEN SURGEON INSERTED A END CAP (5MM), HOWEVER, THERE WAS A STRANGE SOUND, AND THE END CAP WAS STUCK AGAIN. THE SURGERY WAS COMPLETED WITHOUT INSERTING THE END CAP. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 12MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37316 12MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 6L71495 07611819777415