BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER

    MDR report key: 9756566 · Received February 26, 2020

    Report

    Report Number
    8030965-2020-01431
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    PMA / PMN Number
    K172872
    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. VISUAL INSPECTION: THE RETURNED PARTS ARE FUNCTIONING NORMALLY. IT APPEARS WITH THREAD DAMAGES IN PLATE, ARSCREW AND LOCKING SCREW. BELOW IMAGES SHOWS THE FULLY ASSEMBLED CONDITION AND DISASSEMBLED CONDITION OF RETURNED PART, WHICH REPRESENTS THE COMPLAINT CONDITION ¿DEVICE INTERACTION ¿ UNABLE TO DISASSEMBLE¿ IS NOT CONFIRMED AND RETURNED PARTS ARE FUNCTIONING NORMALLY. THE DYNAMIC DESIGN OF THE BOLT ALLOWS IT TO SLIDE ALONG WITH ARSCREW OVER A DISTANCE OF 20MM, WHICH HAS BEEN MENTIONED IN THE SURGICAL TECHNIQUE AND RETURNED DEVICE IS FUNCTIONING PROPERLY. THUS, FNS HAS NO PROBLEM AS MENTIONED IN (B)(4) AS ¿DEVICE INTERACTION - UNABLE TO DISASSEMBLE¿. FUNCTIONAL TEST: FUNCTIONAL TEST PERFORMED AND THE IMPLANTS FUNCTION AS INTENDED. SUMMARY: VISUAL INSPECTION SHOWED NO DESIGN OR FUNCTIONAL RELATED ISSUE; THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. THE PRODUCT INVESTIGATION SHOWS THAT NO ESCALATION IS NEEDED. NO DESIGN DEFECT OR DEFICIENCY DETECTED, THEREFORE THE DCRM REVIEW AND OCCURRENCE RATE CALCULATION IS NOT REQUIRED AND NO FURTHER ACTIONS WILL BE TAKEN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY PART NUMBER: 04.168.500S (SUB COMPONENT PART 60123934), SYNTHES LOT NUMBER: L862842 (SUB COMPONENT LOT L672495), MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 19. APR. 2018, EXPIRY DATE: 01. APR. 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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

    THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEMENT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. (B)(4). 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 (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE (GARDEN IV) WITH FNS IN QUESTION. ON (B)(6) 2020, THE PATIENT UNDERWENT FNS REMOVAL AND THA SURGERY. DURING THE SURGERY, THE SURGEON FOUND THAT THE CUT-OUT HAD OCCURRED. THE ANTI-ROTATION SCREW HAD UNLOCKED AND STUCK OUT OF LATERAL CORTICAL BONE ABOUT 10MM. WHEN THE SURGEON TRIED TO REMOVE THE ANTI-ROTATION SCREW, HE COULD NOT PULL OR PUSH THE SCREW. THERE WAS A RISK OF CAUSING ROTATION OF THE BONE HEAD, HOWEVER, BECAUSE THE SURGEON PLANNED REPLACEMENT THE FNS TO THA, HE REMOVED THEM BY ROTATING THEM COUNTERCLOCKWISE. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CUT-OUT. THIS PC IS ABOUT THE DIFFICULTY REMOVING THE IMPLANTS IN REOPERATION ON (B)(4). CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: TRAUMA (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS 2 OF 3 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221928 ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L862842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - NAIL HEAD ELEMENTS: FNS BOLT| UNK - PLATES: FNS| UNK - SCREWS: TRAUMA