BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE

    MDR report key: 6689276 · Received July 6, 2017

    Report

    Report Number
    1719045-2017-10632
    Event Type
    Injury
    Date Received
    July 6, 2017
    Report Date
    June 8, 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

    DATE RETURNED TO MANUFACTURER SUBJECT DEVICE HAS BEEN RECEIVED AND A PRODUCT INVESTIGATION WAS CONDUCTED/PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE COMPLAINT IS CONFIRMED AS THE BREAKAGE OR THE NAIL IS VISIBLE ON THE RECEIVED X-RAYS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS LOT OF 6 PIECES WAS MANUFACTURED IN MAY 2016 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. A DCRM REVIEW WAS PERFORMED AND IT WAS FOUND THAT THE HARM OF THIS COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. 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

    A PRODUCT INVESTIGATION WAS PERFORMED. THE CONCOMITANT PART TFNA SCREW 95MM (PART # 04.038.195, LOT # H217439, QUANTITY 1) WAS RETURNED WITHOUT AN ALLEGATION AGAINST THEM. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE 04.037.160S, LOT NUMBER H101651, TFNA FEM NAIL Ø11 R 130° L400 TIMO15 WAS RETURNED WITH A CRACK/FRACTURE AT THE AREA OF THE HELICAL BLADE/SCREW INSERTION HOLE OF THE NAIL. IT IS AN OBLIQUE FRACTURE AND THE FRACTURE IS LOCATED 49.67 MM DISTALLY FROM THE PROXIMAL END OF THE NAIL. THE BALANCE OF THE IMPLANT SHOWS SIGNS OF BEING IMPLANTED/REMOVED. THIS COMPLAINT IS CONFIRMED. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY CRACKED. THE 04.037.160S TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IS AN IMPLANT INTENDED FOR TREATMENT OF FRACTURES OF THE FEMUR. RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE DIAMETER OF THE NAIL DIRECTLY PROXIMAL AND DISTAL TO THE FRACTURE POINT BOTH MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS PER RELEVANT DRAWING. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY CAUSED BY INSUFFICIENT REDUCTION OR DELAYED HEALING CAUSING INCREASED LOADS ON THE IMPLANT, THAT WOULD NORMALLY BE SUPPORTED BY THE BONE, WHICH COULD EVENTUALLY CAUSE IT TO CRACK/FRACTURE DUE TO MATERIAL FATIGUE. DURING THE INVESTIGATION, NO 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). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART #: 04.037.160S, LOT#: H101651 (STERILE) - 11MM/130 DEG TI CANN TFNA 400MM/RIGHT- STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA - 9817079; 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 9850960; 04.037.912.3 - TFNA LOCK DRIVE LOT - H041393; 21127 - RAW MATERIAL LOT LOT - H030447. RAW MATERIAL WAS RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST FOR TITANIUM INGOT MEET SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. 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. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 13-MAY-2016, EXPIRATION DATE: 31-MAY-2026. 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

    FIRST AND LAST NAME, EMAIL ADDRESS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A TITANIUM TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS IMPLANTED ON (B)(6) 2017. THE TFNA FRACTURED POST-OPERATIVELY AND WAS REVISED ON (B)(6) 2017 WITH A LATERAL FEMORAL NAIL (LFN). NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (04.038.195S, LOT H217439, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA NAIL, RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THE NAIL BROKE WHERE IT INTERSECTS WITH THE TFNA SCREW. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW (04.038.195S, LOT H217439, QUANTITY 1); CABLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472367 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT H101651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TFNA SCREW (04.038.195S, LOT H217439, QTY 1)