BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE

    MDR report key: 8674792 · Received June 6, 2019

    Report

    Report Number
    2939274-2019-58498
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 18, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDQ
    UDI-DI
    10886982182531
    PMA / PMN Number
    K992891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DEVICE HISTORY LOT MANUFACTURING LOCATION: BRANDYWINE / PACKAGED, STERILIZED AND RELEASED BY: MONUMENT PART NUMBER: 298.803S, 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE LOT NUMBER: H519278 (STERILE) RELEASE TO WAREHOUSE DATE: 05-JAN-2018. EXPIRATION DATE: 30-NOV-2026. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 298.803Y, 4.5 THREADED CERCLAGE POSITIONING PIN. LOT NUMBER: H473346 (NON-STERILE). BRANDYWINE WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, NS044768 REV C MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER:11014, 316L**RI8.00. LOT NUMBER: 9970333. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DATE OF EVENT IS AN UNKNOWN DATE IN 2019. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, AN ABNORMAL RADIOGRAPHIC EVALUATION OCCURRED. THERE WAS A HARDWARE FAILURE AT THE FRACTURE SITE, AS WELL AS ANGULATION OF THE FRACTURE. ONE (1) CERCLAGE CABLE WITH CRIMP, FOUR (4) THREADED CERCLAGE POSITIONING PIN-STERILE, THREE (3) CABLE WITH CRIMP AND ONE (1) TITANIUM CERCLAGE POSITIONING PIN-STERILE WERE IMPLANTED ON (B)(6) 2019. THE ORIGINAL INDICATION FOR USING THE SYNTHES DEVICES WAS FOR TREATMENT OF AN INTRAOPERATIVE FEMUR FRACTURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470666 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE CERCLAGE FIXATION JDQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 298.803S H519278 10886982182531

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention