BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø9MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/LT

    MDR report key: 6544038 · Received May 4, 2017

    Report

    Report Number
    1719045-2017-10423
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    UDI-DI
    07611819400733
    PMA / PMN Number
    K070843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(6). PART 04.031.957, LOT 6230753 (NON-STERILE): COMPONENT PARTS - PART 21012, LOT NUMBER 6028745; RAW MATERIAL LOT BP-80 LOT 7912594: MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: SEPTEMBER 24, 2009. PRODUCT CERTIFICATION MET SPECIFICATION. RAW MATERIAL INSPECTION SHEET MET SPECIFICATION. INSPECTION SHEET FOR INSPECT DIMENSIONAL & INSPECTION SHEET FOR FINAL INSPECTION 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. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: IT WAS REPORTED THAT DURING INSERTION OF THE NAIL IN THE MEDULLARY CANAL THE NAIL DID NOT PASS THROUGH DUE TO AN ALLEGED TOO LARGE DIAMETER. FURTHERMORE, THE TEETH FIXING THE ROTATIONAL ORIENTATION OF THE NAIL TO THE HANDLE HAD BROKEN OFF. THE SURGICAL TECHNIQUE INSTRUCTS ON HOW AND WHEN TO ASSEMBLE AND DISASSEMBLE THE HANDLE TO AND FROM THE NAIL. THERE IS DAMAGE ON THE PROXIMAL END OF THE NAILS, MOST LIKELY DUE TO FORM FIT AND SCREW CONNECTION. THE MARKS INDICATE METAL ON METAL IMPACTING AND LEVERAGING. USE OF A HAMMER IS VISIBLE. A PRODUCT INVESTIGATION WAS COMPLETED: THE INSERTION HANDLE WAS NOT RECEIVED. UPON VISUAL INSPECTION THE RETURNED NAILS HAD BROKEN, BENT, AND CRACKED CONNECTING PROFILE FEATURES AT PROXIMAL END TO HANDLE INTERFACE, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT IT IS LIKELY THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. NO PRODUCT FAULT COULD BE DETECTED. 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

    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 REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING ¿STAMPING¿ THE NAIL FROM THE FEMORAL CHANNEL (DUE TO THE NAIL DIAMETER BEING TOO LARGE IT DID NOT PASSED THROUGH THE ISTHMUS OF THE FEMORAL SHAFT) THE TEETH FIXING THE UNKNOWN INSERTION HANDLE BROKE. THERE WAS A 45 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTED TO BE EXCELLENT. WHEN THE DEVICES WERE BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THAT THE PREVIOUSLY REPORTED CONCOMITANT NAILS WERE DAMAGED. ONE NAIL HAS A NUT IS BROKEN OFF AND THE OTHER ONE IS CRACKED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326361 Ø9MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/LT ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 6230753 07611819400733

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR