BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE

    MDR report key: 8519038 · Received April 16, 2019

    Report

    Report Number
    8030965-2019-62841
    Event Type
    Injury
    Date Received
    April 16, 2019
    Report Date
    March 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819152359
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY . PART: 412.214S, LOT: L956160, MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 28.JUNE 2018, EXPIRY DATE: 01.JUNE 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN MEZZOVICO . PART: 412.214, LOT: L931832, MANUFACTURING SITE: MEZZOVICO , RELEASE TO WAREHOUSE DATE: 19.JUNE 2018 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    EVENT OCCURRED IN (B)(6) 2019; HOWEVER EXACT DATE OF POSTOPERATIVE DEVICE CUT OUT IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN IMPLANT CUT OUT WAS OBSERVED AFTER AN X-RAY WAS TAKEN A WEEK AFTER THE INITIAL SURGERY. INITIALLY, THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019, WHEREIN A FEMORAL NECK SYSTEM (FNS) WAS APPLIED DUE TO A FEMORAL NECK FRACTURE. THE SURGEON COMMENTED THAT THERE WAS A POSSIBILITY THAT THE NECK BOLT WAS INSERTED ANTERIORLY THAN THE PROPER POSITION WHICH HAD CAUSED THE EVENT, AND A POSSIBILITY THAT RETROTORSION OF THE REDUCTION SITE MIGHT HAVE OCCURRED. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2019, WHERE THE FNS WAS REMOVED AND WAS REPLACED WITH TOTAL HIP ARTHROPLASTY (THA) SYSTEM. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW SELF-TAPPING. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312587 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L956160 07611819152359

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention