BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9678484 · Received February 6, 2020

    Report

    Report Number
    8030965-2020-00928
    Event Type
    Injury
    Date Received
    February 6, 2020
    Report Date
    January 17, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819152359
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT DHR REVIEW CONFIRMED THAT LOT L765854 BELONGS TO THE NON-STERILE PART 412.214, WHICH WAS STERILIZED AT FRÜH AG, THE STERILE LOT NUMBER IS L791130 PART: 412.214S, LOT: L791130, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 23 FEB 2018, EXPIRY DATE: 01 FEB 2028. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY DHR REVIEW IS DONE FOR NON-STERILE PART: PART NUMBER: 412.214, LOT NUMBER: L765854, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 08 FEB 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON-STERILE DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY INVESTIGATION SELECTION INVESTIGATION SITE: ZUCHWIL , SELECTED FLOW: ADVERSE EVENT - NO REPORTED PRODUCT PROBLEM . VISUAL INSPECTION: ALL RECEIVED DEVICES, THE "BOLT" (04.168.275S); THE "PL 1-HO" (04.168.000S); THE "ANTIROTSCR" (04.168.475S); THE "LOCKSCR Ø5" (412.214S) SHOWS SIGNS OF USE. THE PLATE AND THE LOCKING SCREW WERE FOUND JAMMED TOGETHER. FURTHERMORE, THE ANODIZED LAYER IS WORN AWAY AT THE DAMAGES WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. SUMMARY: OUR INVESTIGATION HAS SHOWN THAT THE RECEIVED DEVICES HAVE SIGNS OF USE ON THEIR SURFACES. THIS INVESTIGATION WILL BE RATED AS UNCONFIRMED, BECAUSE NO PRODUCT RELATED ISSUE WAS IDENTIFIED THAT COULD HAVE CAUSED THE REPORTED NECROSIS. THE JAMMING ISSUE, BETWEEN THE "LOCKSCR Ø5" (412.214S) AND THE "PL 1-HO" (04.168.000S) WAS ALREADY INVESTIGATED WITH NO MANUFACTURING RELATED ISSUES AS A RESULT. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE 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

    OCCUPATION: SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 THAT THE PATIENT WAS UNDERWENT A SURGERY WITH THE FNS. AFTER THE SURGERY, ON AN UNKNOWN DATE, THE SURGEON CONFIRMED THAT FEMORAL HEAD NECROSIS OCCURRED. ON (B)(6) 2020, THE PATIENT UNDERWENT THE REMOVAL SURGERY AND BHA SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140558 . 5.0MM TI LOCKING SCR SLF-TPNG . W/T25 STARDRIVE 40MM-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L791130 07611819152359

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention