BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 6893152 · Received September 26, 2017

    Report

    Report Number
    3006126083-2017-10042
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 6, 2017
    Manufacturer
    SYNTHES RARON
    Product Code
    LXH
    UDI-DI
    10886982197214
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE REPORT INDICATES THAT THE: IT WAS REPORTED THAT THE ROTATING LEVER OF A TITANIUM ELASTIC NAIL INSERTER (359.219 LOT 3242304) BROKE WHILE ATTEMPTING TO INSERT THE FIRST NAIL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH AN ALTERNATIVE INSTRUMENT WITHOUT SURGICAL DELAY. THE RETURNED INSERTER WAS EXAMINED UPON RECEIPT AND THE COMPLAINT CONDITION AND WAS ABLE TO BE CONFIRMED AS THE DEVICES ROTATING LEVER WAS FOUND TO BE BROKEN AT THE HOLE WHICH ALIGNS WITH THE INSTRUMENTS CANNULATION; BOTH PIECES OF THE ROTATING LEVER WERE RETURNED. UPON FURTHER EXAMINATION, IT WAS DETERMINED THAT THE DEVICE¿S CHUCK FUNCTIONED AS INTENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ERRANT HAMMER BLOWS. WITNESS MARKS WERE IDENTIFIED ON BOTH PIECES OF THE ROTATING LEVER CONSISTENT WITH HAMMER IMPACTION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL CHECK AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. 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

    PATIENT ID: (B)(6). PATIENT WEIGHT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: SEPTEMBER 07, 2009. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 THE PATIENT HAD AN ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A FOREARM FRACTURE TO THE ULNA AND RADIUS BONES. THE PATIENT WAS IMPLANTED WITH TWO (2) 2.5MM TITANIUM (TI) ELASTIC NAILS. DURING THE PROCEDURE, AS THE SURGEON WAS USING THE INSERTER INSTRUMENT TO IMPLANT THE FIRST NAIL, THE HANDLE BROKE AND THE BOLT AT THE END OF THE HANDLE SPLIT IN HALF AND FELL ONTO THE OPERATING ROOM FLOOR. THE SURGEON SELECTED ANOTHER INSERTER INSTRUMENT THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THE PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 2.5MM TITANIUM (TI) ELASTIC NAIL 440MM (PART 475.925, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674481 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES RARON 3242304 10886982197214

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR