BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FEM NAIL Ø10 LE 130° L235 TIMO15

    MDR report key: 6758406 · Received August 1, 2017

    Report

    Report Number
    1719045-2017-10725
    Event Type
    Injury
    Date Received
    August 1, 2017
    Report Date
    July 19, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED. THE FOLLOWING DEVICES WERE RECEIVED TFNA NAIL (PART 04.037.045, LOT H067788), HELICAL BLADE (PART 04.038.410, LOT 9855190) AND STARDRIVE LOCKING SCREW (PART 04.005.532, LOT L029599). A DEVICE HISTORY RECORD (DHR)REVIEW, DEVICE INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE NAIL IS BROKEN IN 2 PIECES AT THE LOCKING SCREW HOLE. THE COMPLAINT CANNOT BE REPLICATED DUE TO BEING BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THIS INVESTIGATION. THE 04.037.045 TFN-ADVANCED¿ PROXIMAL FEMORAL NAILING SYSTEM IS INTENDED FOR TREATMENT OF FRACTURES IN ADULTS AND ADOLESCENTS (12-21) IN WHICH THE GROWTH PLATES HAVE FUSED PER RELEVANT TECHNIQUE GUIDE. VISUAL INSPECTION REVEALED THAT THE NAIL IS BROKEN IN 2 PIECES AT THE MID LOCKING SCREW HOLE. IN ADDITION, THE ANODIZE SURFACE FINISH HAS BEEN WORN OFF. THE HELICAL BLADE WAS ALSO WORN WHERE THE BLADE ENTERS THE RECEIVING END OF THE NAIL. THE PRONG OF THE LOCKING CAP WAS DEFORMED AND REMAINED INSIDE THE NAIL. THE THREADS OF THE STARDRIVE LOCKING SCREW WERE SEVERELY DEFORMED AND GALLED. RELEVANT DRAWINGS WERE REVIEWED. IT IS SUSPECTED THE MOTION OF THE UNSTABLE ELEMENT CHAFED AND WORN THE LOCKING SCREW THREADS. REVIEW OF THE BROKEN IMPLANTS DETERMINED THAT THE COMPLAINT CONDITION IS THE RESULT OF FORCES BEYOND THE YIELD STRENGTH OF THE MATERIAL. A BREAK OF THIS NATURE WOULD REQUIRE SIGNIFICANT FORCE AND WOULD NOT BE EXPECTED WHEN USED AND IMPLANTED AS RECOMMENDED. HOWEVER, SINCE IT IS UNKNOWN WHEN AND HOW THE DAMAGE OCCURRED, A ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DURING THE INVESTIGATION, NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE RETURNED TO MANUFACTURER. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 07-APR-2016 , EXPIRATION DATE: 30-APR-2026. PART #: 04.037.045S, LOT#: H067788 (STERILE) - 10MM/130 DEG TI CANN TFNA 235MM / LEFT - STERILE. QTY 5. INSPECTION SHEET FOR TFNA ASSEMBLY MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT - 9859513, PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7921063 , PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - H020813 . PART 21127 - RAW MATERIAL LOT BP-80 LOT - 9902536. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FROM (B)(4) FOR TITANIUM AND RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. 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: (B)(4) ETHICON (ABQ), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A LOCKING BOLT BROKE 2 MONTHS POSTOPERATIVELY. NO INFORMATION ABOUT PATIENT STATUS. AFTER MATERIAL WAS RETURNED, IT WAS DETECTED THAT THE NAIL BROKE AT THE LEVEL OF THE LOCKING BOLT. THE LOCKING BOLT IS DAMAGED AS WELL. THIS COMPLAINT INVOLVES 1 PARTS. CONCOMITANT DEVICE: 1X TFNA HELICAL BLADE, 04.038.410/ (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537547 TFNA FEM NAIL Ø10 LE 130° L235 TIMO15 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H067788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention