BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 10347422 · Received July 30, 2020

    Report

    Report Number
    2939274-2020-03330
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    July 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. VISUAL INSPECTION: THE RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER (P/N: 03.033.003, LOT NUMBER: L963559) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, BOTH CAM LOCK LEVERS WERE MISSING FROM THE DEVICE. THERE WAS NO BROKEN FRAGMENTS REMAINING ON THE DEVICE OR RETURNED. THE REMAINDER OF THE DEVICE DISPLAYED NO OTHER ALTERATION OR DAMAGE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSION INSPECTION WAS PERFORMED ON THE RETURNED DEVICE DUE TO THE POST MANUFACTURING DAMAGE OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THE RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER (P/N: 03.033.003, LOT NUMBER: L963559) WAS RETURNED WITH BOTH CAM LOCK LEVERS MISSING FROM THE DEVICE. NO BROKEN FRAGMENTS WERE FOUND WITH THE RETURNED DEVICE OR WERE STILL ATTACHED TO IT; HENCE THE COMPLAINT IS NOT CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE MISSING COMPONENTS BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION CONDUCTED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 PREVENTIVE 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 LOT PART: 03.033.003, LOT: L963559, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: SEP 27, 2018. 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 · 1

    REPORTER IS A J&J EMPLOYEE. THE DEVICE HAS BEEN 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN THE CONSULTANT WAS PREPARING THE SET FOR STERILIZATION IT WAS NOTICED BOTH OF THE PLASTIC TABS ON THE SIDE OF THE RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER WERE BROKEN OFF. IT IS UNSURE WHERE OR WHEN THE DAMAGE TOOK PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806989 RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.033.003 L963559 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1