BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER

    MDR report key: 10326128 · Received July 27, 2020

    Report

    Report Number
    2939274-2020-03302
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Report Date
    June 12, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188281
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: CORRECTION: G1: MANUFACTURING SITE NAME AND ADDRESS. 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

    REPORTER IS A SYNTHES EMPLOYEE. PART #: 313.969, SYNTHES LOT NUMBER: 4222059, MANUFACTURING SITE: SYNTHES (B)(4), RELEASE TO WAREHOUSE DATE: JANUARY 16, 2001. 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 HOLDING SLEEVE FOR 3.0 MM CANNULATED SCREWDRIVER (P/N: 313.969, LOT #: 4222059) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS MISSING SPRING. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS NOT PERFORMED AS THE RETURNED DEVICE WAS MISSING COMPONENTS. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? YES. DIMENSIONAL INSPECTION: THERE WAS CONCLUSIVE EVIDENCE THAT THE RETURNED DEVICE WAS MISSING A COMPONENT, SO THE DIMENSIONAL INSPECTION WAS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. -HOLDING SLEEVE COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS MISSING A COMPONENT THAT COULD HAVE CAUSED THE COMPLAINT CONDITION. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE HOLDING SLEEVE FOR 3.0 MM CANNULATED SCREWDRIVER (P/N: 313.969, LOT #: 4222059). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO DEVICE MAINTENANCE AND INCORRECTLY REASSEMBLED AFTER THE STERILIZATION PROCESS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT AND THE HOLDING SLEEVE FOR CANNULATED SCREWDRIVER WOULD NOT SPRING BACK INTO PLACE. THE CANNULATED AWL HAD PITTING AND DENTS ON THE BLADE. THERE WAS NO PATIENT INVOLVEMENT. DETERMINED TO BE A REPORTABLE MALFUNCTION ON JULY 24, 2020. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE FOR 3.0 MM CANNULATED SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789371 HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 313.969 4222059 10886982188281

    Patients

    Seq Age Sex Outcome Treatment
    1