BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAILS-STER

    MDR report key: 7355437 · Received March 20, 2018

    Report

    Report Number
    8030965-2018-52264
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    February 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819789494
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HSB. DEVICE WAS NOT EXPLANTED COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DHR REVIEW WAS COMPLETED PART NO.: 04.005.416S LOT NO.: L175649 MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 24.OCT.2016 EXPIRY DATE: 01.OCT.2026 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 04.005.416 / L163393 WAS MANUFACTURED IN (B)(4) RELEASE TO WAREHOUSE DATE: 10.OCT.2016 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE TO REPAIR A HUMERAL NECK FRACTURE ON (B)(6) 2018 UTILIZING THE MULTILOC HUMERAL NAILING (MHN) SYSTEM. TWO WEEKS POST-OP, PATIENT WAS SYMPTOMATIC OF RADIAL NERVE PARALYSIS. SURGEON SUSPECTED THE DISTAL SCREWS MAY BE TOUCHING THE PATIENT¿S NERVE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE SURAL NERVE WAS TRANSPLANTED INTO THE RADIAL NERVE BECAUSE THE RADIAL NERVE WAS PARTIALLY TORN. NO HARDWARE WAS REMOVED DURING THIS PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 360 MINUTE DELAY. THIS REPORT IS FOR ONE (1) 4.0MM LOCKING SCREW 26MM THIS IS REPORT 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196899 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAILS-STER SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L175649 07611819789494

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention