BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 6072718 · Received November 2, 2016

    Report

    Report Number
    3006126083-2016-10041
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 11, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-0125-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 359.219, LOT # 1811056. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 17, 2008. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE 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.

    Additional Manufacturer Narrative · 1

    PATIENT GENDER IS NOT PROVIDED FOR REPORTING. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (INSERTER FOR TI ELASTIC NAILS, PART NUMBER 359.219, LOT NUMBER 1811056). THE INSERTER WAS RETURNED BROKEN INTO MULTIPLE PIECES. THE HANDLE IS BROKEN AT THE PROXIMAL END OF THE DEVICE. THE BLUE HANDLE IS INTACT BUT SEPARATED FROM THE DEVICE. THE CONCOMITANT ELASTIC NAIL WAS RETURNED WITH THE DEVICE AND IS STUCK IN THE CHUCK OF THE INSERTER. THE NAIL IS BENT IN HALF, AND SOME OF THE ANODIZATION IS WORN, LIKELY DUE TO HANDLING OF THE DEVICE. THIS APPEARS TO BE POST-MANUFACTURING RELATED, AND DOES NOT RELATE TO THE COMPLAINT CONDITION. NO FURTHER INVESTIGATION OF THE ELASTIC NAIL IS NECESSARY, AS THERE IS NO COMPLAINT, AND THERE IS NO DEVICE DEFICIENCY NOTED DURING EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT IS CONFIRMED. THE INSERTER FOR TITANIUM ELASTIC NAILS (359.219) IS USED WITH A HAMMER GUIDE AND LOCKING SLIDE HAMMER FOR INSERTION OF TITANIUM ELASTIC NAILS (TEN) AND STAINLESS STEEL ELASTIC NAILS (STEN). THE INSERTER IS ALSO USED IN END CAP INSERTION AND REMOVAL. THIS INFORMATION IS PROVIDED PER THE ELASTIC NAIL SYSTEM TECHNIQUE GUIDE. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING AT THE TIME OF MANUFACTURE WAS PERFORMED. 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. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE COMPLAINT CONDITION IS MOST LIKELY ASSOCIATED WITH ROUGH HANDLING VIA ERRANT HAMMER BLOWS. 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 WHILE IMPLANTING A 4.0MM TI ELASTIC NAIL FOR A TIBIA FRACTURE, THE INSERTER IT WAS REPORTED THAT ON (B)(6) 2016, WHILE IMPLANTING A 4.0MM TI ELASTIC NAIL FOR A TIBIA FRACTURE, THE INSERTER BROKE. THE SURGEON WAS USING THE INSERTER TO IMPACT THE NAIL INTO THE TIBIA WHEN THE TOP PORTION OF THE HANDLE BROKE OFF. THE INSERTER BROKE INTO TWO PIECES AS A CLEAN BREAK. THE BREAKAGE DID NOT GENERATE ANY FRAGMENTS. THERE WAS A 30 MINUTE SURGICAL DELAY. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. STANDARD X-RAYS WERE TAKEN THROUGHOUT THE PROCEDURE, UNRELATED TO THE DEVICE BREAKAGE. THE SURGEON USED ANOTHER INSERTER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT STATUS WAS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: 4.0MM TI ELASTIC NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724609 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES RARON 1811056

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR ONE (1) UNKNOWN 4.0MM TI ELASTIC NAIL