BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 10673924 · Received October 13, 2020

    Report

    Report Number
    2939274-2020-04639
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    September 22, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE INTER-LOCK SCREWDRIVER T25/3.5 MM HEX/224 MM (P/N: 03.010.473, LOT #: 9920539) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DEVICE WAS DEFORMED. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE THAT THE TIP IS DAMAGED. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS NOT DETERMINED. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED YES, THE DEVICE RECEIVED WAS DEFORMED. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE INTER-LOCK SCREWDRIVER T25/3.5 MM HEX/224 MM (P/N: 03.010.473, LOT #: 9920539). 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 UNINTENDED FORCES APPLIED TO THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED.: REPORTER IS A J&J SALES CONSULTANT. THE INSTRUMENT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S). THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION OF BROKEN WAS NOT CONFIRMED AS THE IMAGE(S) SHOWED NOTHING BROKEN IN REGARDS TO THE INSTRUMENT. AS THE INSTRUMENT(S) WAS NOT RETURNED AND AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO ISSUES WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS IT WAS UNCONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING, AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 03.010.473. LOT NUMBER: 9920539. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 16. SEP. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2020, THE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM WAS BROKEN. IT WAS DISCOVERED, AND OCCURRED TODAY WHILE DOING INSPECTION, NOT IN SURGERY AND THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137985 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.473 9920539 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1