BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CORTEX SCREW 36MM

    MDR report key: 7261782 · Received February 9, 2018

    Report

    Report Number
    8030965-2018-51017
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED DATA: DEVICE IS A SINGLE USE DEVICE BUT WAS NOT REPROCESSED OR REUSED. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 404.036S, LOT# 9825033. MANUFACTURING LOCATION: GRENCHEN, RELEASE TO WAREHOUSE DATE: FEB 22, 2016, EXPIRY DATE: FEB 01, 2026. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 9825033 WAS MANUFACTURED FROM BLANK 404.036.999 LOT 9865621 THAT WAS MANUFACTURED IN US, MONUMENT. MANUFACTURING LOCATION: MONUMENT; RELEASED ON AUG 21, 2015. COMPONENT PARTS REVIEWED: PART: 23040 LOT: 7891194 (TITANIUM). RAW MATERIAL RECEIVED FROM PERRYMAN COMPANY. PRODUCT CERTIFIED TEST REPORT FOR TITANIUM RECEIVED FROM PERRYMAN MEET SPECIFICATION. APPROVED CERTIFICATE FOR TITANIUM WAS PROVIDED BY TIMET MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. THE INVESTIGATION HAS CONFIRMED THAT THE CORTEX SCREW IS BROKEN OFF AS COMPLAINED ¿ SCREW HEAD IS STILL JAMMED WITHIN EXTRACTION BOLT AND COULD NOT BE DISASSEMBLED. DIMENSIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DAMAGE INCURRED. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED. THE INVESTIGATION FOUND NO PRODUCT RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION AND WE ARE NOT AWARE OF ANY QUALITY ISSUES WITH THESE ART/ LOT NUMBERS. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 THE EXPLANT PROCEDURE ON (B)(6) 2018 WAS PLANNED SURGERY. PATIENT OUTCOME WAS REPORTED AS OKAY. REPORTEDLY, THE 14TH SCREW BROKE AND STUCK WITH THE EXTRACT BOLT. THE SURGEON ABORTED REMOVING THE 15TH SCREW. ADDITIONALLY, FURTHER REMOVAL SURGERY MAY BE CONDUCTED TO REMOVE THE BROKEN SCREW AND ONE INTACT SCREW THAT WERE LEFT IN THE PATIENT. CONCOMITANT DEVICE REPORTED: EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS (PART# 309.039, LOT# 2774558, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ID, PATIENT, DOB & AGE NOT PROVIDED FOR REPORTING. (B)(4) ,UDI UNAVAILABLE. NOT EXPLANTED: THE 14TH SCREW WAS BROKEN OFF, AND A CHIPPED FRAGMENT STUCK WITHIN THE BOLT. DATE RETURNED TO MANUFACTURER. (B)(6). ADDITIONAL 510K: K131186 HRS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DEVICES WERE USED IN EXPLANT SURGERY FOR DISTAL TIBIA FRACTURE ON (B)(6) 2018. THE SURGEON CONNECTED EXTRACT BOLT IN QUESTION TO A HANDPIECE AND REMOVED 13 OUT OF 15 LOCKING HEAD SCREWS. THEN, THE 14TH SCREW WAS BROKEN OFF, AND A CHIPPED FRAGMENT STUCK WITH THE BOLT. THE SURGEON ABORTED TO REMOVE THOSE TWO REMAINING SCREWS AND FINISHED THE SURGERY. THE ENTIRE SURGERY TOOK MORE THAN FIVE HOURS, BUT HOW MUCH TIME WAS DELAYED IS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED FROM THE HOSPITAL. CONCOMITANT PARTS: 1X 309.039 EXTRACT-BOLT F/SCR Ø3.5+4. THIS COMPLAINT INVOLVES 1 PARTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101893 3.5MM TI CORTEX SCREW 36MM SCREW, FIXATION,BONE HWC SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM 9825033

    Patients

    Seq Age Sex Outcome Treatment
    1