BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 13169228 · Received January 5, 2022

    Report

    Report Number
    2939274-2022-00014
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 1, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982297396
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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. H10 ADDITIONAL NARRATIVE: D4; D9. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE AIMING ARM/ RADIOLUCENT (PN: 03.043.029, LN: 2024221) WAS RECEIVED WITH A BROKEN LATCH. THE FAILURE IS A BREAKAGE OF THE CARBON-FIBER REINFORCED LATCH. THE FAILURE MODE IS AN INTERLAMINAR BREAKAGE DUE TO SHEAR FORCES. BREAKAGE IS MOST LIKELY FAVORED BY DEFECTS IN THE STRUCTURE OF THE CARBON FIBER REINFORCED PEEK PLATE. IT IS IN THE NATURE OF THE MATERIAL THAT THE SHEAR STRENGTH IS HIGHLY ANISOTROPIC AND LOWEST BETWEEN CARBON FIBER LAYERS. LIKELY INTERLAMINAR SHEAR STRENGTH IS REDUCED BY DEFECTS RESULTING FROM MANUFACTURING ISSUES NOT LEADING TO COMPLETE BOND BETWEEN THE CARBON LAYERS. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE COMPLEX GEOMETRY OF THE PART. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF DATE OF MANUFACTURED, THE CURRENT AND THE MANUFACTURED DRAWINGS WERE REVIEWED. NO DESIGN ISSUE OR DISCREPANCY IS FOUND. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE AIMING ARM/ RADIOLUCENT (PN: 03.043.029, LN: 2024221). THE ROOT CAUSE OF THE COMPLAINT CONDITION CAN BE CONFIRMED AS THE MANUFACTURING/PROCESSING ERROR WITH THE CARBON FIBER LAYERS. JNJ NR IS OPENED TO FURTHER DETERMINE THE MANUFACTURING/PROCESS ERROR THAT CAUSE THE COMPLAINT CONDITION. ANY FURTHER CORRECTIVE/PREVENTIVE ACTIONS IF REQUIRED WILL BE DETERMINE UNDER NR. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 03.043.029 -US. LOT # 2024221. MANUFACTURING SITE: SELZACH. RELEASE TO WAREHOUSE DATE: 09 APR2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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 · 0

    IT WAS REPORTED ON (B)(6) 2021, THE AIMING ARM/RADIOLUCENT WAS FOUND TO HAVE BROKEN PIECES BROKEN OFF IN THE INSTRUMENT ROOM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643769 AIMING ARM/ RADIOLUCENT SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.043.029 2024221 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown