BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 11445723 · Received March 9, 2021

    Report

    Report Number
    2939274-2021-01258
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 12, 2021
    Report Date
    February 11, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982194442
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR (P/N 352.251S, LOT # 17P3092) WAS RECEIVED AT US CQ BROKEN WITH BROKEN PROXIMAL PRONGS. THE BROKEN FRAGMENTS WERE NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DEVICE FAILURE/DEFECT WAS IDENTIFIED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR (P/N 352.251S, LOT # 17P3092) AS THE DEVICE WAS BROKEN. THE UNINTENDED EXTERNAL FORCES MIGHT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE 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: PART # 352.251S, SYNTHES LOT # 17P3092, SUPPLIER LOT # 17P3092, RELEASE TO WAREHOUSE DATE: MAR 18, 2020, EXPIRATION DATE: JAN 31, 2029, SUPPLIER: (B)(4). JBL-NR-0002536 WAS GENERATED AS THE AQL WAS INCORRECT ON THE INSPECTION SHEET. PARTS WERE RE-INSPECTED USING AN F-S145. PER W-G-S025 REINSPECTION HAS NO ADVERSE EFFECT ON THE PRODUCT. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE RIA REAMING ROD AND REAMING DRIVE SHAFT BROKE. FRAGMENTS WERE NOT GENERATED OR LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339715 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 352.251S 17P3092 10886982194442

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA