BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 14MM --STERILE

    MDR report key: 6515061 · Received April 23, 2017

    Report

    Report Number
    2520274-2017-11473
    Event Type
    Malfunction
    Date Received
    April 23, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 31, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: (B)(6) 2016. EXPIRY DATE: (B)(6) 2026. 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. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. ONE (1) 1.5MM TI CORTEX SCREW SELF-TAPPING WITH T4 STARDRIVE RECESS 14MM (PART # 04.214.114S, LOT # L103250) WAS RECEIVED. THE SCREW WAS RECEIVED BROKEN AT SCREW'S THREADED SHAFT. FURTHERMORE WE FOUND THAT THREAD FLANKS OF BROKEN PART ARE FLAT. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. BECAUSE OF THE DAMAGE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY. UNFORTUNATELY WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. WE DO SUPPOSE THAT THE CAUSE OF THE BREAKAGE IS THE RESULT OF A MECHANICAL OVERLOAD SITUATION DURING USE. BASED ON THE INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SYNTHES MANUFACTURING FACILITY WAS INCORRECTLY REPORTED IN INITIAL MEDWATCH REPORT #(B)(4). 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 INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS HRS. OTHER NUMBER¿UDI: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. IT IS UNKNOWN WHICH ¿AGENCY¿ RECEIVED THE REPORTED SCREW. THE FACILITY THAT THE SUBJECT DEVICE EVENT OCCURRED IS REPORTED. REPORTING FACILITY PHONE NUMBER IS +(B)(6). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. REPORTING FACILITY PHONE NUMBER IS (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED FOR THE SUBJECT DEVICE LOT. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A BROKEN CORTEX SCREW WAS SENT BACK FROM AN AGENCY OUTSIDE JOHNSON AND JOHNSON (SYNTHES) SUPPLY. THE CORTEX SCREW WAS USED IN SURGERY ON (B)(6) 2017. THE CORTEX SCREW IS BROKEN BUT IT¿S UNKNOWN WHEN THIS HAPPENED. A SURGICAL DELAY OF UNKNOWN DURATION WAS REPORTED. THERE IS NO INFORMATION AVAILABLE ABOUT THE SURGERY, PATIENT AND SURGICAL OUTCOME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296359 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 14MM --STERILE SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN L103250

    Patients

    Seq Age Sex Outcome Treatment
    1