BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE

    MDR report key: 6046641 · Received October 21, 2016

    Report

    Report Number
    3009417901-2016-10041
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. PART NUMBER: 04.019.000S, SYNTHES LOT NUMBER: 5936231: RELEASE TO WAREHOUSE DATE: OCTOBER 7, 2015. MFG. SITE: (B)(4). 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 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. NO PRODUCT FAULT COULD BE DETECTED. ARTICLE 04.019.000S, LOT 5936231. THE INVESTIGATION OF THE RETURNED TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE HAS SHOWN NO OBVIOUS DAMAGES OR DEVIATIONS. A FUNCTIONAL TEST TOGETHER WITH THE RESPONSIBLE SUSTAINING ENGINEER HAS SHOWN THAT THE END CAP COULD BE INSERTED IN A NAIL WITHOUT ANY PROBLEMS. THE MEASUREMENTS OF THE END CAP DURING THE PRODUCTION OF THE PARTS HAVE SHOWN NO DEVIATIONS TO THE SPECIFICATION. THE COMPLAINT CONDITION FOR THIS PART CANNOT BE REPLICATED. ARTICLE 04.019.005S, LOT 5925314. THE INVESTIGATION OF THE RETURNED TI MULTILOC END CAP F/MULTILOCNAIL/5MM EXTENSION-STERILE HAS SHOWN THAT THE THREAD IS STRONGLY DAMAGED AND ONE THREAD FLANK IS CRACKED. THIS IS A CLEAR INDICATION THAT TOO MUCH MECHANICAL FORCE WAS USED DURING INSERTION OF THE ENDCAP. A FUNCTIONAL TEST TOGETHER WITH THE RESPONSIBLE SUSTAINING ENGINEER HAS SHOWN THAT THE END CAP COULD BE INSERTED DESPITE THE DEFECTIVE THREAD IN A NAIL WITHOUT ANY PROBLEMS. THE MEASUREMENTS OF THE END CAP DURING THE PRODUCTION OF THE PARTS HAVE SHOWN NO DEVIATIONS TO THE SPECIFICATION. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE ASSUMED THAT THE END CAP WAS TRIED TO INSERT WITH FORCE AND IN A WRONG ANGLE INTO THE NAIL WHICH HAS FINALLY LET TO THE CRACK AT THE THREAD FLANK. DEVICE WAS NOT IMPLANTED. (B)(4). 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 (B)(4) REPORTS AN EVENT IN THE (B)(6) IS AS FOLLOWS; IT WAS REPORTED THAT THE SURGEON HAD PROBLEMS WITH THE TITANIUM MULTILOC END CAP. IT WAS DIFFICULT TO GET A PROPER GRIP IN THE 8.5MM TITANIUM MULTILOC HUMERAL NAIL SO THE SURGEON LEFT THE NAIL IN THE PATIENT WITHOUT END CAP. THE OPERATION TIME WAS EXTENDED THIRTY (30) MINUTES. NO PATIENT HARM OCCURRED. CONCOMITANT DEVICES REPORTED: 8.5MM TITANIUM MULTILOC HUMERAL NAIL LEFT/CANNULATED/210MM-STERILE (PART # 04.019.210S, LOT # UNKNOWN, QUANTITY #1). THIS IS REPORT NUMBER 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699729 TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SALZBURG 5936231

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR 8.5MM NAIL (PART # 04.019.210S)