BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI CANNULATED HUMERAL NAIL-EX/220MM-STERILE

    MDR report key: 6595364 · Received May 26, 2017

    Report

    Report Number
    1719045-2017-10510
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    May 2, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS (B)(6). DATE OF POSTOPERATIVE NON-UNION DEVELOPMENT IS UNKNOWN. UDI: (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS PART WAS DISCARDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART #: 04.001.224S, LOT#: 7063838 (STERILE) - 7MM TI CANNULATED HUMERAL NAIL-EX/220MM-STERIL. QTY: 6: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 20-DEC-2012 (LOT 7142143 WAS CONVERTED TO LOT 7063838 UNDER HOLD # 1457). EXP: 31-DEC-2021, EXPIRATION DATE: 30-SEP-2021: COMPONENTS: RAW MATERIAL PART 21039 BP80 LOT 6804436. RAW MATERIAL WAS RECEIVED FROM SUPPLIER (B)(4). PRODUCT CERTIFICATION RECEIVED FROM (B)(4) INCORPORATED MEET SPECIFICATION. INSPECTION SHEET- FOR FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. NO NON CONFORMANCE REPORTS (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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT A PATIENT, WHO WAS IMPLANTED WITH A SYNTHES EX HUMERAL NAIL AND TWO (2) UNKNOWN 4.0MM LOCKING SCREWS ON (B)(6) 2016, WAS NOTED TO HAVE A NON-UNION. THE PATIENT WAS REVISED ON (B)(6) 2017, WHERE THE HUMERAL NAIL AND LOCKING SCREWS WERE REMOVED INTACT AND THE PATIENT WAS REVISED TO A SYNTHES LARGE FRAG, 10-HOLE BROAD PLATE, AND ABOUT EIGHT SCREWS. VIVIGEN CELLULAR BONE GRAFT MATERIAL WAS ALSO USED IN THE FRACTURE SITE. THERE WERE NO SURGICAL DELAYS AND THE PREVIOUSLY IMPLANTED HARDWARE WAS EASILY REMOVED WITHOUT ANY ADDITIONAL PATIENT HARM OR MEDICAL INTERVENTION. THE EXPLANTED DEVICES WERE DISCARDED; AS SUCH THEY ARE NOT AVAILABLE FOR INVESTIGATION. THE PATIENT WAS REPORTED TO BE STABLE AT THE END THE PROCEDURE. THIS REPORT IS FOR ONE (1) 7MM TI CANNULATED HUMERAL NAIL-EX/220MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375461 7MM TI CANNULATED HUMERAL NAIL-EX/220MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT 7063838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention