BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 9643953 · Received January 29, 2020

    Report

    Report Number
    2939274-2020-00526
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    January 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982196255
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. G3: REPORTER IS MILLSTONE MEDICAL SERVICE PROVIDER. H3, H6: PART: 357.402. SYNTHES LOT: 6993104. SUPPLIER LOT: NA. RELEASE TO WAREHOUSE DATE: AUGUST 06, 2012. MANUFACTURED BY SYNTHES JENNERSVILLE. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED COMPONENTS OF THE DEVICE. NO DEVICE FAILURE/DEFECT WAS IDENTIFIED. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS UNCONFIRMED FOR THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE 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 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 DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, A LOCKING BOLT MEASURING DEVICE WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106895 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.402 6993104 10886982196255

    Patients

    Seq Age Sex Outcome Treatment
    1