BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE

    MDR report key: 10021961 · Received May 4, 2020

    Report

    Report Number
    2939274-2020-02223
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 20, 2020
    Report Date
    April 20, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982074980
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. H3, H6: INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 03.124.004, LOT: 7881237, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 23.MAY.2012. 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.

    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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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, DURING AN UNKNOWN PROCEDURE, THE NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE WAS DIFFICULT TO THREAD ONTO THE INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE. THE TECHNICIAN WAS UNABLE TO USE THE 2 DEVICES TO ATTACH THE UNKNOWN AIMING ARM TO THE UNKNOWN PLATE. THE SURGEON HAD TO ASSIST THE TECHNICIAN AT THE BACK OF THE TABLE TO COMPLETE THE ASSEMBLY. THE SURGEON HAD TO STOP WHAT HE WAS DOING TO ASSIST THE TECHNICIAN IN THE ASSEMBLY OF THE PARTS TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS TOO DIFFICULT TO THREAD AND HAVE THESE 2 DEVICES LOOKED AT. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484689 NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.124.004 7881237 10886982074980

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 2.8MM INTRLKNG BLT FR PRCTNUS INSRTN HNDLE| NT FR INTLKNG BLTS FR PRCTNUS INSRTN HANDL| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM| UNK - PLATES