BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANNULATED HUMERAL NAIL-EX/240MM

    MDR report key: 4784298 · Received May 20, 2015

    Report

    Report Number
    3000270450-2015-10105
    Event Type
    Injury
    Date Received
    May 20, 2015
    Report Date
    April 29, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    PK033071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). EVENT DATE: DATE OF ONSET FOR POSTOPERATIVE PAIN/IRRITATION IS UNKNOWN. STERILE PART ¿ (B)(4); NON-STERILE PART ¿ (B)(4). IMPLANT DATE: DEVICE WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2013. COMPLAINANT PART IS NOT EXPECTED FOR RETURN. MANUFACTURING DATE FOR STERILE PART ¿ FEBRUARY 7, 2013; MANUFACTURING DATE FOR NON-STERILE PART ¿ JANUARY 17, 2013. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY (DHR) RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES FOR THIS PART. PART NUMBER: 04.001.428, LOT NUMBER: 7206013, RAW MATERIAL NUMBER: (B)(4), MANUFACTURE DATE: JANUARY 17, 2013, EXPIRATION DATE: N/A. PLEASE NOTE - THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEBRUARY 7, 2013, EXPIRY DATE: JANUARY 1, 2023. NO NON-CONFORMANCE REPORTS 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 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 UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015 DUE TO ROTATOR CUFF IRRITATION. DURING THE PROCEDURE, A HUMERAL NAIL, TWO (2) 4MM LOCKING SCREWS, AND ONE (1) END CAP WERE REMOVED. IT WAS NOTED THAT THE NAIL HAD NOT ¿SUNK DOWN ENOUGH¿ AND WAS ¿STICKING UP LATERALLY.¿ THIS OUTCOME WAS ATTRIBUTED TO THE TECHNIQUE USED DURING THE INITIAL PROCEDURE THAT TOOK PLACE ON AN UNKNOWN DATE IN (B)(6) 2013. THE FRACTURE WAS HEALED AND NO COMPLAINTS WERE MADE AGAINST THE DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF SURGICAL DELAY. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329773 9MM TI CANNULATED HUMERAL NAIL-EX/240MM NAIL, FIXATION, BONE JDS SYNTHES SELZACH 7206013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention