BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE

    MDR report key: 6763146 · Received August 3, 2017

    Report

    Report Number
    1719045-2017-10732
    Event Type
    Injury
    Date Received
    August 3, 2017
    Report Date
    July 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (THERAPY DATE): UNKNOWN DATE FOUR MONTH PRIOR TO EXPLANT ON (B)(6) 2017. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. STERILE PART 04.037.056S, LOT H058149: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MARCH 17, 2016. EXPIRATION DATE: FEBRUARY 28, 2026. COMPONENT PARTS: LOCK PRONG, 130 DEGREE, TFNA BP-55 (PART 04.037.942.2, LOT 9831888); WAVE SPRING, SHIM ENDED BP-55 (PART 04.037.912.4, LOT 7921056); TFNA LOCK DRIVE BP-58 (PART 04.037.912.3, LOT 9982275); RAW MATERIAL LOT BP-80 (PART 21127, LOT H047833). RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FROM (B)(4) FOR TITANIUM MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. 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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REVISION (EXCHANGE NAILING) WAS PERFORMED ON (B)(6) 2017 DUE TO NAIL BREAKAGE AND NON-UNION. THE PATIENT WAS TREATED FOUR (4) MONTHS PRIOR TO THE REVISION PROCEDURE WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR A DISTAL THIRD FEMUR FRACTURE. THE NAIL HAD BROKEN AT THE DISTAL LOCKING HOLE. ON AN UNKNOWN DATE THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PAIN. AN X-RAY TAKEN IN THE ER REVEALED THE NAIL HAD BROKEN AT THE DISTAL LOCKING HOLE. NO INFORMATION WAS AVAILABLE REGARDING PATIENT ACTIVITY OR ANY CONTRIBUTING FACTORS WHICH MAY HAVE LED TO THE DEVICE FAILURE. ALL HARDWARE WAS REMOVED AND THEY DID AN EXCHANGE NAILING (REPLACED WITH A 12 X 380 MM RIGHT, ANOTHER HELICAL BLADE AND ONE LOCKING SCREW). THE PROCEDURE WENT SMOOTHLY. ALL NAIL FRAGMENTS WERE RETRIEVED; NOTHING WAS LEFT IN THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTIONS OR UNANTICIPATED X-RAYS WERE DONE. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE 85 MM STERILE (PART 04.038.285S, LOT H271333, QUANTITY 1); 2.5 MM LOCKING SCREW (36 MM) (QUANTITY 1); 2.5 MM LOCKING SCREW (40 MM) (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544274 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H058149

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention ONE PART 04.038.285S, LOT H271333, TFNA BLADE| ONE UNKNOWN 2.5MM LOCKING SCREW (36MM)| ONE UNKNOWN 2.5MM LOCKING SCREW (40MM)