BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM MEDULLARY REAMER HEAD

    MDR report key: 11762569 · Received May 3, 2021

    Report

    Report Number
    2939274-2021-02201
    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
    10886982194244
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: THE SUBJECT 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.

    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. THE COMPLAINT CONDITION IS CONFIRMED FOR THE SYNREAM REAMER HEAD Ø12 (P/N: 352.120, LOT # 2081229).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 HISTORY LOT: DUE TO THE AGE OF MORE THAN 10 YEARS OF THE COMPLAINED DEVICE A WEAR OR USE RELATED ROOT CAUSE IS THE MOST LIKELY REASON OF THE COMPLAINED MALFUNCTION. PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE IS FOR COMPLAINTS FOR WHICH A NON-MANUFACTURING RELATED PROBABLE CAUSE HAS BEEN IDENTIFIED NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 8 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657755 12.0MM MEDULLARY REAMER HEAD REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.120 2081229 10886982194244

    Patients

    Seq Age Sex Outcome Treatment
    1 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 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