BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LXH INSERTER FOR TI ELASTIC NAILS

    MDR report key: 6350770 · Received February 22, 2017

    Report

    Report Number
    3003875359-2017-10081
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Report Date
    January 30, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982197214
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/ EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 359.219 LOT: 9428457; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 23. JUN. 2015. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (LXH INSERTER FOR TI ELASTIC NAILS, PART NUMBER 359.219, LOT NUMBER 9428457). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: THE HANDLE IS CRACKED AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THERE IS NO VISIBLE SIGN OF MISUSE. THE BREAK IS TYPICAL FOR BRITTLE MATERIAL AND STARTED AT THE ANGLE OF SHORTEST DISTANCE SHOWING SOME FORCE INTRODUCTION. EVEN IF THE OCCURRENCE RATE AND SEVERITY OF HARM ARE ADDRESSED ADEQUATELY IN THE CURRENT RISK MANAGEMENT DOCUMENTATION AN INTERNAL DESIGN EVALUATION REGARDING THE FAILURE MODE DESCRIBED IN THIS COMPLAINT HAS BEEN PERFORMED. THE DESIGN OF THE HANDLE (GEOMETRY AND MATERIAL) HAS BEEN CHANGED TO ADDRESS THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. WE CAN ONLY REASONABLY CONCLUDE THAT A MECHANICAL OVERLOAD SITUATION HAS LED TO THE DAMAGE. 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 BLUE PLASTIC HANDLE OF A TITANIUM ELASTIC NAIL (TEN) INSERTER BROKE INTRAOPERATIVELY. FRAGMENTS WERE GENERATED, BUT IT IS UNKNOWN WHETHER THEY WERE REMOVED EASILY OR DIFFICULTLY. THERE WAS NO PATIENT HARM AND NO PROLONGATION OF SURGERY REPORTED. COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133048 LXH INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 9428457 10886982197214

    Patients

    Seq Age Sex Outcome Treatment
    1