BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10.5MM MEDULLARY REAMER HEAD

    MDR report key: 8578932 · Received May 3, 2019

    Report

    Report Number
    2939274-2019-57828
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 7, 2019
    Report Date
    April 7, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194213
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PART 352.105, LOT 2061461: MANUFACTURING SITE: BETTLACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: MAY 05, 2003. A DEVICE HISTORY RECORD (DHR) IS NOT AVAILABLE AS DEVICE IS OLDER THAN 18 YEARS. A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE RETURNED DEVICE AT CUSTOMER QUALITY SHOWED THAT THE REAMER HEAD WAS BROKEN INTO PIECES. THE FRAGMENTS GENERATED DURING BREAKAGE WERE NOT RETURNED. NO FURTHER ISSUES WERE NOTED. DIMENSIONAL INSPECTION WAS NOT POSSIBLE DUE TO THE POST MANUFACTURING DAMAGE. THE RELEVANT DRAWING WAS REVIEWED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED EXCESSIVE FORCES DURING USAGE WHICH COULD HAVE CONTRIBUTED TO REPORTED COMPLAINT CONDITION. THE OVERALL COMPLAINT CONDITION IS CONFIRMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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. 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.

    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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE MEDULLARY REAMER HEAD WAS MAKING A CONTROL PASS STARTED THAT THE BONE CUTTING REAMER 8 1/2 WITH A 9-9 1/2 AND 10,10 1/2, MET SOME RESISTANCE IN THE DIAPHYSIS AND NOTICED A POP, AN X-RAY WAS TAKEN AND IT WAS NOTICED THAT HALF OF THE REAMER SHEARED OFF IN THE FEMUR. THE PIECE THAT SHEARED OFF IS STILL IN THE PATIENT WITHOUT ANY DISRUPTION TO THE REST OF THE CASE. THEY RETAINED THE BROKEN HALF OF THE REAMER THAT WAS NOT RETRIEVED ON THE REAMER SHAFT. THE SURGEON TOOK X-RAYS TO CONFIRMED THAT THE SHEARED PIECE DID NOT LEAVE EXIT THE INTRAMEDULLARY (IM) CANAL. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES TO PULL BACK THE REAM SHAFT AND REMAINING REAMER HEAD THAT WAS STILL SECURE ON THE REAMER. SURGERY WAS SUCCESSFUL AS THEY CONTINUED TO PLACE THE INTRAMEDULLARY (IM) NAIL INTO THE FEMUR WITHOUT ANY PROBLEMS OR EVENTS. CONCOMITANT DEVICES REPORTED: UNK - REAMERS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369791 10.5MM MEDULLARY REAMER HEAD REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.105 2061461 10886982194213

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention UNK - REAMERS: TRAUMA| UNK - REAMERS: TRAUMA