BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 10612962 · Received October 1, 2020

    Report

    Report Number
    2939274-2020-04407
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Report Date
    September 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWX
    UDI-DI
    10886982187390
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. VISUAL INSPECTION THE HANDLE WITH QUICK COUPLING (PART #: 311.43 AND LOT #: 5890501) WAS RETURNED AND RECEIVED AT US CQ. A VISUAL INSPECTION WAS PERFORMED. THE ENDCAP COMPONENT (311.43.4) IS PRESS FIT ONTO THE HANDLE DURING MANUFACTURING, WHICH WAS OBSERVED TO BE BROKEN AND WAS NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING CURRENT AND MANUFACTURING DRAWINGS WERE REVIEWED: TAP HANDLE FOR SMALL TAPS AND CSK TAP HANDLE ENDCAP TAP HANDLE . COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION FOR THE HANDLE WITH QUICK COUPLING (PART #: 311.43 AND LOT #: 5890501) WAS CONFIRMED AS THE ENDCAP COMPONENT WAS BROKEN. NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 PART #: 311.43, SYNTHES LOT #: 5890501, MANUFACTURING SITE: SYNTHES BRANDYWINE , RELEASE TO WAREHOUSE DATE: 16-OCT-2008. 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

    OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. 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 AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082541 HANDLE WITH QUICK COUPLING, SMALL TAP, BONE HWX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 311.43 5890501 10886982187390

    Patients

    Seq Age Sex Outcome Treatment
    1