BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM UNIVERSAL FEMORAL NAIL 440MM

    MDR report key: 11404137 · Received March 3, 2021

    Report

    Report Number
    8030965-2021-01548
    Event Type
    Injury
    Date Received
    March 3, 2021
    Report Date
    February 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    07611819011618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 AN UNKNOWN DATE, THE PATIENT¿S ROD BROKE POST-OP. ON (B)(6) 2015 THE PATIENT UNDERWENT A PROCEDURE FOR AN ORTHOPEDIC IMPLANT WITH AN INTRAMEDULLARY NAIL AND SCREWS. THE PATIENT WAS DISCHARGED AND UNDERWENT MEDICAL FOLLOW-UP FROM (B)(6) 2015 TO (B)(6) 2016. IN (B)(6) 2017 THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN IN HIS RIGHT THIGH AND KNEE. ON (B)(6) 2017 THE BROKEN METAL ROD WAS FOUND. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION SURGERY. CONCOMITANT DEVICES REPORTED: BOLT Ø4.9 SELF-TAP L52 SS (PART NUMBER 259.52, LOT 9231482, QUANTITY 1). BOLT Ø4.9 SELF-TAP L56 SST (PART NUMBER 259.56, LOT 9233289, QUANTITY 1). BOLT Ø4.9 SELF-TAP L64 SST (PART NUMBER 259.64, LOT 3357366, QUANTITY 1). BOLT Ø4.9 SELF-TAP L68 SST (PART NUMBER 259.680S, LOT UNKNOWN, QUANTITY 1). RODS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 12MM UNIVERSAL FEMORAL NAIL 440MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302171 12MM UNIVERSAL FEMORAL NAIL 440MM NAIL, FIXATION, BONE JDS SYNTHES GMBH 9392457 07611819011618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOLT Ø4.9 SELF-TAP L52 SST| BOLT Ø4.9 SELF-TAP L56 SST| BOLT Ø4.9 SELF-TAP L64 SST| BOLT Ø4.9 SELF-TAP L68 SST| UNK - RODS