BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 36MM

    MDR report key: 7952866 · Received October 10, 2018

    Report

    Report Number
    8030965-2018-57173
    Event Type
    Injury
    Date Received
    October 10, 2018
    Report Date
    September 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819124783
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 212.212, LOT: 9901870, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 08. APRIL 2016: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 80 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE VISUAL INSPECTION HAS SHOWN THAT THE THREAD FLANKS OF THE SCREW ARE SLIGHTLY WORN, WHICH CAN BE TRACED BACK TO THE INSERTION AND/OR EXTRACTION OF THE SCREW. SUMMARY: THE SCREW IN QUESTION WAS RETURNED WITHOUT SPECIFIC ALLEGATION. THE VISUAL INSPECTION DID NOT IDENTIFY ANY UNEXPECTED DAMAGE, WHICH COULD HAVE CAUSED A MALFUNCTION OF THE SCREW. THEREFORE, AND AS THE DHR REVIEW HAS SHOWN THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATION IS THE COMPLAINT UNCONFIRMED FOR THE SCREW. 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. 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 · 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. IMPLANT DATE: EXACT DATE IS UNKNOWN. 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 · 0

    IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT INITIAL IMPLANT PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018. FURTHER, UPON REMOVAL OF THE DEVICES, SURGEON AGREED THAT THERE WAS INFECTION, TISSUE AND SWAB WERE TAKEN. REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL PRODUCT CODES: HRS, HWC. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED; THE INVESTIGATION IS IN PROGRESS. NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2018 DUE TO FAILED VARIABLE-ANGLE LOCKING COMPRESSION PLATE (VA-LCP) AND POSSIBLE INFECTION ISSUE. EXPLANTED IMPLANTS ARE AS FOLLOWS: ONE (1) 4.5MM VARIABLE ANGLE CURVED CONDYLAR PLATE (VA-LCP), ONE (1) LOCKING SCREW 60MM, THREE (3) LOCKING SCREW 65MM, ONE (1) LOCKING SCREW 36MM, AND THREE (3) LOCKING SCREW 30MM. ORIGINAL IMPLANT DATE IS UNKNOWN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY NOTED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 36MM. THIS REPORT IS 6 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795334 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 36MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9901870 07611819124783

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention