BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE

    MDR report key: 8007207 · Received October 25, 2018

    Report

    Report Number
    8030965-2018-57650
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    January 1, 2018
    Report Date
    October 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089830
    PMA / PMN Number
    K172872
    Adverse Event
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART: 04.168.285S; LOT: L874470; MANUFACTURING LOCATION: GRENCHEN; SUPPLIER: FRUEH AG; RELEASE TO WAREHOUSE DATE: APRIL 26, 2018; EXPIRY DATE: APRIL 01, 2028 THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND STERILIZATION CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. LOT WAS RELEASED AFTER CHECKING STERILIZATION PARAMETERS FROM SUPPLIER BY QA. 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. PRODUCT WAS NOT RETURNED. 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

    COMPLAINANT PART IS EXPECTED NOT TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION.(B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. 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 A BURSECTOMY SURGERY ON (B)(6) 2018 DUE TO INFECTION. PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR THE FEMORAL NECK FRACTURE USING A PLATE FOR FEMORAL NECK SYSTEM (FNS), TITANIUM ALLOY (TAN), BOLT FOR FNS, ANTIROTATION SCREW, GUIDE WIRE AND A LOCKING SCREW ON (B)(6) 2018. DURING THE ORIF PROCEDURE, THE SURGEON NOTICED THE LACK OF THE BOLT FOR CONSTRUCT LENGTH 80MM; THUS, USED THE BOLT 85MM AS AN ALTERNATIVE. ON (B)(6) 2018, THE HOSPITAL FOUND THAT THE PATIENT DEVELOPED AN INFECTION. REOPERATION WAS PERFORMED TO CLEAN THE AFFECTED SITE. PATIENT WAS UNDER PARTIAL WEIGHT BEARING. THE SURGERY WAS COMPLETED WITHOUT DELAY. PATIENT OUTCOME WAS UNKNOWN.   THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846015 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE APPLIANCE, FIXATION, BONE KTT OBERDORF SYNTHES PRODUKTIONS GMBH L874470 07612334089830

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention