BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE

    MDR report key: 7652669 · Received June 29, 2018

    Report

    Report Number
    8030965-2018-54741
    Event Type
    Injury
    Date Received
    June 29, 2018
    Report Date
    June 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819651340
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE 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. DATE OF EXPLANTATION IS KNOWN. ITEM: 04.037.258S; LOT: H376614; MANUFACTURING QUANTITY: (B)(4); MANUFACTURING DATE: JUNE 02, 2017; MANUFACTURING LOCATION: MONUMENT; SCN: 13799; EXPIRATION DATE: MAY 01, 2027 PRODUCT WAS INSPECTED AND PASSED. THERE ARE NO RELEVANT NONCONFORMANCE REPORTS (NCRS). RAW MATERIAL (RM) LOT NUMBER H210699. RM WAS ORIGINALLY RECEIVED FROM METALWERKS PMD, INC ON 07 OCT 2016 ALONG WITH A CERTIFICATE OF ANALYSIS. CERTIFICATION INDICATTES MATERIAL MEETS ES0473, REV B EXCEPT AS MODIFIED BY SYNTHES DRAWING TIMOAGRI16.00, REV C. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST INDICATES ALL REQUIREMENTS WERE MET. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS MATERIAL. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION BASED ON THE RECEIVED PICTURES. 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PATIENT ETHNICITY IS UNKNOWN. ADDITIONAL INFORMATION REGARDING THE REVISION PROCEDURE. DATE OF CONCOMITANT THERAPY IS THE SAME AS DATE OF IMPLANTATION; AN UNKNOWN DATE IN NOVEMBER 2017. 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

    PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. THE SURGEON ALSO REMOVED A HELICAL BLADE AND AN UNKNOWN NUMBER OF UNKNOWN SCREWS. CONCOMITANT DEVICES: TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1)

    Additional Manufacturer Narrative · 1

    PATIENT ID AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. DATE OF IMPLANT IS AN UNKNOWN DATE IN (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, PATIENT UNDERWENT IMPLANT PROCEDURE FOR SUBTROCH FRACTURE/PATHOLOGICAL FRACTURE SECONDARY TO METASTATIS. PATIENT HAD ONGOING AND INCREASING PAIN. X-RAYS IN MARCH CONFIRMED NONUNION OF FRACTURE. HAD AN INCREASED IN PAIN OVER PAST WEEK. X-RAYS SHOWED NAIL BREAKAGE. PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE AND THE NAIL WAS REMOVED AND TOTAL HIP JOINT REPLACEMENT WAS COMPLETED. PATIENT AND SURGERY OUTCOME WERE REPORTED AS UNEVENTFUL. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495678 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H376614 07611819651340

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THERAPY DATE: NOVEMBER 2017