BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER

    MDR report key: 6046326 · Received October 21, 2016

    Report

    Report Number
    1719045-2016-10770
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    October 19, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 08, 2014. EXPIRATION DATE: AUGUST 31, 2023. 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. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR SUBJECT DEVICE (11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER, PART #: 456.418S, LOT#: 7810795). THE RETURNED NAIL WAS FOUND TO BE BROKEN AT THE PROXIMAL LOCKING HOLE. THE DEVICE SHOWS SOME WEAR CONSISTENT WITH IMPLANTATION AND REMOVAL, BUT IS OTHERWISE IN GOOD CONDITION. THE RETURNED CONCOMITANT HELICAL BLADE SHOWS SOME WEAR CONSISTENT WITH IMPLANTATION AND REMOVAL, BUT IS OTHERWISE IN GOOD CONDITION. A VISUAL INSPECTION, DIMENSIONAL TEST, DRAWING REVIEW AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED. THE RETURNED TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL IS AN IMPLANT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE DRAWINGS (11MM TROCHANTERIC FIXATION NAIL ¿ RIGHT, 11MM TFN NAIL BODY, RIGHT) WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. THE INNER DIAMETER AT THE BREAKAGE SITE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE OUTER DIAMETER OF THE NAIL AT THE PROXIMAL TIP WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. THE RETURNED CONCOMITANT DEVICE IN THIS COMPLAINT RECORD SHOWS NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT, AND NO ISSUE WAS IDENTIFIED WITH THE CONCOMITANT DEVICE UPON A VISUAL INSPECTION. THEREFORE, REVIEW TO THE SPECIFIC DESIGN OR MANUFACTURING RISK ASSESSMENT (DCRM/PRM) AND DCRM/PRM LINE IS NOT APPLICABLE; AND AN OCCURRENCE RATE CALCULATION IS NOT REQUIRED. THE EXACT CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED. 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

    ADDITIONAL PRODUCT CODE: HWC. (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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    THE BROKEN DEVICE WAS EASILY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED ON OCTOBER 19, 2016 A REVISION SURGERY TOOK PLACE TO REMOVE A TROCHANTERIC FIXATION NAIL (TFN) IMPLANT FROM A PATIENT BECAUSE IT BROKE. A NEW TFN NAIL WAS IMPLANTED. THE ORIGINAL PROCEDURE WAS AN INTRAMEDULLARY (IM) NAILING FOR A RIGHT HIP FRACTURE ON AN UNKNOWN DATE. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART 456.304, LOT 9809434, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698864 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7810795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HELICAL BLADE (456.304)