BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

    MDR report key: 6069751 · Received November 1, 2016

    Report

    Report Number
    1719045-2016-10801
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT WEIGHT IS (B)(6). UDI # - (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.437S, LOT# 9943617. RELEASE TO WAREHOUSE DATE: DECEMBER 8, 2015. EXPIRATION DATE: OCTOBER 31, 2017, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2016 PATIENT UNDERWENT INITIAL IMPLANTATION OF A LEFT TIBIAL NAIL VIA A SUPRAPATELLAR APPROACH TO TREAT A TIBIAL FRACTURE. DURING THE PROCEDURE, AN OUTER PROTECTION SLEEVE BROKE INTO PIECES DURING A SURGICAL PROCEDURE. AFTER THE NAIL WAS IMPLANTED, THE SURGEON WITHDREW THE OUTER PROTECTION SLEEVE AND NOTED THAT IT HAD BROKEN INTO A NUMBER OF PIECES. AN ADDITIONAL INCISION WAS MADE AND THE PIECES WERE RETRIEVED INTACT. THERE WAS A 25 MINUTE SURGICAL DELAY. IT WAS REPORTED THAT ADDITIONAL X-RAYS WERE TAKEN WHICH SHOWED NO PIECES REMAINING IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. THE NAIL WAS SUCCESSFULLY IMPLANTED. CONCOMITANT DEVICE REPORTED: 10MM PROXIMAL BEND TIBIAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721190 12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE NAIL, FIXATION, BONE JDS SYNTHES MONUMENT 9943617

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention