BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5MM MEDULLARY REAMER HEAD

    MDR report key: 11762228 · Received May 3, 2021

    Report

    Report Number
    2939274-2021-02200
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 7, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    07611819243750
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE SYNREAM REAMER HEAD Ø11.5 (P/N: 352.115, LOT # 2082345) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION DEVICE IS SLIGHTLY DEFORMED WHICH MIGHT BE THE REASON FOR THE CONDITION. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS NOT PERFORMED AS THE DEVICE WAS RECEIVED BY ITSELF. HOWEVER, THE ALLEGED DULL/WILL NOT CUT CONDITION CAN BE CONFIRMED DUE TO THE DEFORM CONDITION. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE SYNREAM REAMER HEAD Ø11.5 (P/N: 352.115, LOT # 2082345).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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 352.115, SYNTHES LOT # 4720362, SUPPLIER LOT # 2082345, RELEASE TO WAREHOUSE DATE: 09 FEB 2004, SUPPLIER: (B)(4). 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE REAMER HEADS WERE DULL. THIS LED TO UNNECESSARY REAMER PASSES AND INCREASED PROCEDURE TIME. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO (2) MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658827 11.5MM MEDULLARY REAMER HEAD 11.5MM MEDULLARY REAMER HEAD HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2082345 07611819243750

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNREAM REAMER HEAD ø12| SYNREAM REAMER HEAD Ø10| SYNREAM REAMER HEAD Ø10| SYNREAM REAMER HEAD Ø10.5| SYNREAM REAMER HEAD Ø10.5| SYNREAM REAMER HEAD Ø11| SYNREAM REAMER HEAD Ø11| SYNREAM REAMER HEAD Ø11.5| SYNREAM REAMER HEAD Ø12| SYNREAM REAMER HEAD Ø8.5| SYNREAM REAMER HEAD Ø8.5| SYNREAM REAMER HEAD Ø9| SYNREAM REAMER HEAD Ø9| SYNREAM REAMER HEAD Ø9.5| SYNREAM REAMER HEAD Ø9.5| SYNREAM REAMER HEAD ø12| SYNREAM REAMER HEAD Ø10| SYNREAM REAMER HEAD Ø10| SYNREAM REAMER HEAD Ø10.5| SYNREAM REAMER HEAD Ø10.5| SYNREAM REAMER HEAD Ø11| SYNREAM REAMER HEAD Ø11| SYNREAM REAMER HEAD Ø11.5| SYNREAM REAMER HEAD Ø12| SYNREAM REAMER HEAD Ø8.5| SYNREAM REAMER HEAD Ø8.5| SYNREAM REAMER HEAD Ø9| SYNREAM REAMER HEAD Ø9| SYNREAM REAMER HEAD Ø9.5| SYNREAM REAMER HEAD Ø9.5