BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 6414867 · Received March 17, 2017

    Report

    Report Number
    1719045-2017-10235
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Report Date
    February 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: HELICAL BLADE: (PART NUMBER 04.038.315S, LOT NUMBER 7953069, QUANTITY 1), LOCKING SCREW (PART NUMBER 04.005.530, LOT NUMBER UNKNOWN, QUANTITY 1) DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 20-MAR-2015, EXPIRATION DATE: 31-JAN-2025, PART #: 04.037.142S, LOT#: 7928945 (STERILE) - 11MM/130 DEG TI CANN TFNA 170MM - STERILE. QUANTITY 5. INSPECTION SHEET FOR IN PROCESS/INSPECT DIMENSIONAL/FINAL NS063042 REV: E MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 130 DEGREE, TFNA BP-55 LOT - 9218988 & 9228854, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7722153, 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 7818886, 21127 - RAW MATERIAL LOT BP-80 LOT - 7420591. NO 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. SCN NO: 11118, ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY REVIEW REVEALED NO 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. NO FURTHER INVESTIGATION IS POSSIBLE. 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

    PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION DUE TO HELICAL BLADE MIGRATION. DURING THE REVISION, THE EXTRACTOR WAS ATTACHED TO THE NAIL AND THE LOCKING MECHANISM WAS BACKED OFF. THE HELICAL BLADE AND DISTAL 5.0MM LOCKING SCREW WERE REMOVED. SURGEON THEN MANUALLY PULLED ON THE EXTRACTOR AND ONLY THE PROXIMAL PORTION OF THE NAIL WAS EXTRACTED, LEAVING THE DISTAL PORTION OF THE NAIL IN THE FEMORAL CANAL. THE NAIL WAS BROKEN FROM THE HELICAL BLADE HOLE DOWN. THE HELICAL BLADE & SCREW COUPLING SCREW WAS THEN INSERTED DOWN INTO THE FEMORAL SHAFT AND THREADED INTO THE DISTAL PORTION OF THE NAIL. ONCE THREADED, SURGEON WAS ABLE TO GENTLY BACK SLAP THE COUPLING SCREW AND REMOVE THE REMAINDER OF THE NAIL. WHEN ALL HARDWARE WAS REMOVED, PATIENT WAS REVISED TO A HEMIARTHROPLASTY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THIS COMPLAINT ADDRESSES THE BROKEN NAIL. THE REVISION DUE TO HELICAL BLADE MIGRATION IS ADDRESSED IN (B)(4). THIS COMPLAINT IS FOR 1 DEVICE CONCOMITANT DEVICES REPORTED: HELICAL BLADE: (PART NUMBER 04.038.315S, LOT NUMBER 7953069, QUANTITY 1), LOCKING SCREW (PART NUMBER 04.005.530, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196579 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7928945

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR