BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNREAM REAMING ROD Ø2.5 SHORT L950

    MDR report key: 13581137 · Received February 22, 2022

    Report

    Report Number
    8030965-2022-01049
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    January 24, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07611819287518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. 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. PRODUCT CODE #:352.032, SYNTHES LOT #:334898, MANUFACTURING SITE: WERK SELZACH LOGISTIK, RELEASE TO WAREHOUSE DATE: SEPTEMBER 15, 2020, SUPPLIER: HIPP MEDICAL AG. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NON-STERILE ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 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. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SYNREAM REAMING ROD Ø2.5 SHORT L950 WAS FOUND TO BE BROKEN AT ONE OF THE ENDS. EMBEDDED DEVICE CONDITION CANNOT BE CONFIRMED AS X-RAY EVIDENCE OR PHOTOS WERE NOT PROVIDED. A DIMENSIONAL INSPECTION FOR THE SYNREAM REAMING ROD Ø2.5 SHORT L950 WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SYNREAM REAMING ROD Ø2.5 SHORT L950 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A RIGHT FEMUR PROCEDURE ON (B)(6) 2022, THE SYNREAM 2.5 GUIDEWIRE WAS CUT AND LEFT INSIDE THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS IS EXCELLENT. THIS REPORT IS FOR A SYNREAM REAMING ROD Ø2.5 SHORT L950. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799860 SYNREAM REAMING ROD Ø2.5 SHORT L950 REAMER HTO SYNTHES GMBH 334898 07611819287518

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention