BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.5MM MEDULLARY REAMER HEAD

    MDR report key: 11995416 · Received June 14, 2021

    Report

    Report Number
    2939274-2021-02937
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 20, 2021
    Report Date
    May 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    07611819243835
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. H10 ADDITIONAL NARRATIVE: PART#: 352.155, SYNTHES LOT#: 5161128, SUPPLIER LOT#: 2155762, RELEASE TO WAREHOUSE DATE: JANUARY 27, 2006, SUPPLIER: SYNTHES GMBH, NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE SYNREAM REAMER HEAD Ø15.5 (PART#: 352.155, LOT#: 2155762) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION IT WAS FOUND THAT THE FLANGES OF THE REAMING HEAD IS LITTLE DEFORMED/DISTORTED. THIS MIGHT BE DUE TO IT'S USAGE IN THE OPERATIVE ENVIRONMENT FOR REAMING PURPOSE. NO OTHER VISUAL DEFECT WERE OBSERVED WITH THE DEVICE. HENCE THE COMPLAINT CONDITION CANNOT BE CONFIRMED FOR REAMER HEAD. DEVICE FAILURE/DEFECT IDENTIFIED? NO. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURED, THE CURRENT AND THE MANUFACTURED DRAWINGS WERE REVIEWED: REAMER HEAD: CURRENT AND MANUFACTURED REVISIONS. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION CANNOT BE CONFIRMED FOR THE RECEIVED SYNREAM REAMER HEAD Ø15.5 (PART#: 352.155, LOT#:2155762). 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.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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) 2021 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR, WHILE THE SURGEON WAS REAMING THE FEMUR WITH A 15.5MM SYNTHES FLEXIBLE REAMER, THE REDUCTION WAS LOST AT THE FRACTURE SITE AND THE REAMER GOT STUCK IN THE CANAL. THE REAMER SHAFT WAS BROKEN. THE BALL TIP GUIDE WIRE HELD EVERYTHING AND THE BROKEN PIECES WERE REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 15.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887938 15.5MM MEDULLARY REAMER HEAD REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2155762 07611819243835

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR SYNREAM FLEXSHAFT.| SYNREAM FLEXSHAFT