BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE

    MDR report key: 6795788 · Received August 15, 2017

    Report

    Report Number
    1719045-2017-10777
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    July 31, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF NON-UNION IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. UDI: (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS CONDUCTED FOR PART #: 04.004.452S, LOT#: H177097 (STERILE) ¿. QUANTITY 6. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE SHEET AND INSPECTION SHEET FOR FINAL INSPECTION MEET SPECIFICATION. COMPONENT PARTS REVIEWED: PART 21012 LOT: 9958922 REVIEWED. RAW MATERIAL RECEIVED FROM (B)(4). CERTIFIED TEST REPORT RECEIVED FROM (B)(4) FOR TITANIUM MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEETS REQUIREMENT. (B)(4) INITIATED ON 22-AUG-2016 AT OPERATION 20 ¿ GUNDRILL DUE TO JBS RELATED ISSUE, (WHEN IMPLEMENTING THE JBS FOR GUN DRILL IN THE NAIL DEPARTMENT, SIX PACK HOLDERS ARE CALLED OUT ON (B)(4) THESE ARE STILL AWAITING PRODUCTION DUE TO MACHINE TIMES.). (B)(4) WAS CREATED AT OPERATION 170 ¿ BOXING AND MON_SHRINK ON 24-AUG-2016 FOR THIS IS A PLANNED NON-CONFORMANCE. IT DOES NOT REQUIRE TO REPEAT STEPS 3.08 AND 3.09 FOR EACH PART WHICH IS NOT RELATED TO COMPLAINT CONDITION OF NON-UNION OF THE TIBIA BONE. 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.¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 07-SEP-2016. EXPIRATION DATE: 31-JUL-2025. 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 REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A LEFT TIBIA FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) EX 10MM TI CANNULATED TIBIAL NAIL 360MM AND FIVE (5) VARIOUS LENGTHS OF 5.0MM LOCKING SCREWS. TWO (2) 5.0MM LOCKING SCREW OF UNKNOWN SIZE WERE IMPLANTED AT THE PROXIMAL PORTION OF THE TIBIA. THREE (3) 5.0MM LOCKING SCREW OF UNKNOWN SIZE WERE IMPLANTED AT THE DISTAL PORTION OF THE TIBIA. ON AN UNKNOWN DATE POST-OPERATIVELY, PATIENT PRESENTED WITH A NON-UNION AT THE THIRD DISTAL PORTION OF THE TIBIA BONE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A COMPETITOR¿S TIBIA NAIL IMPLANT. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 10MM CANNULATED TIBIAL NAIL-EX. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575977 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT H177097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention