BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE

    MDR report key: 6883627 · Received September 21, 2017

    Report

    Report Number
    1719045-2017-10962
    Event Type
    Injury
    Date Received
    September 21, 2017
    Report Date
    August 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS (B)(6).. ADDITIONAL PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT REPORTED AS (B)(6). DATE OF DEVICE MIGRATION IS NOT KNOWN. (B)(4). 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. DHR REVIEW WAS COMPLETED. PART #: 04.034.340S, LOT#: 9917818 (STERILE) - 9MM TI CANN TIBIAL NAIL - EX W/PROX BEND 300MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 21012 LOT 7993496 REVIEWED. RAW MATERIAL WAS RECEIVED FROM SUPPLIER PERRYMAN COMPANY, CERTIFICATE OF TEST FOR TITANIUM INGOT RECEIVED FROM PERRYMAN COMPANY MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEETS SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE, FINAL INSPECTION & INSPECT DIMENSIONAL MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 14-OCT-2015. EXPIRATION DATE: 30-SEP-2024. 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 UNDERWENT A HARDWARE REMOVAL AND REVISION DUE TO TIBIA NAIL MIGRATION ON (B)(6) 2017. THE ORIGINAL TIBIA FRACTURE REPAIR PROCEDURE WAS PERFORMED ON (B)(6). 2017. POSTOPERATIVELY, THE PATIENT WAS NOT COMPLIANT WITH HER NON-WEIGHT BEARING STATUS, AND SUBSEQUENTLY IT WAS DISCOVERED THAT THE NAIL HAD MIGRATED THROUGH THE ANTERIOR CORTEX OF THE TIBIA. IT IS NOTED THAT THE PATIENT SUFFERS FROM SEVERE ALCOHOL ABUSE. THE HARDWARE REMOVAL INCLUDED: ONE TIBIA NAIL (INTACT), AND FIVE LOCKING SCREWS (INTACT). THE ORIGINAL FRACTURE SITE APPEARED TO BE HEALING NORMALLY. THE PATIENT WAS REVISED WITH A PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 4.0MM TI LOCKING SCREW WITH T25 (PART 04.005.450, LOT NUMBER UNKNOWN, QUANTITY 1), 4.0MM TI LOCKING SCREW WITH T25 (PART 04.005.428, LOT NUMBER UNKNOWN, QUANTITY 1), 4.0MM TI LOCKING SCREW WITH T25 (PART 04.005.422, LOT NUMBER UNKNOWN, QUANTITY 1), 4.0MM TI LOCKING SCREW WITH T25 (PART 04.005.420, LOT NUMBER UNKNOWN, QUANTITY 1), 4.0MM TI LOCKING SCREW WITH T25 (PART 04.005.440, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 9MM CANNULATED TIBIAL NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663420 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT 9917818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention