BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 12489377 · Received September 17, 2021

    Report

    Report Number
    2939274-2021-05533
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 22, 2021
    Report Date
    August 22, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. PART: 03.043.029 LOT: 2023566 MANUFACTURING SITE: SELZACH SUPPLIER: (B)(4) MANUFACTURED DATE: DECEMBER 28, 2020 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE AIMING ARM/ RADIOLUCENT (PN: 03.043.029, LN: 2023566) WAS RETURNED TO R&D TEAM IN ZUCHWIL. DURING THE ANALYSIS OF THE COMPLAINTS TWO SUBCATEGORIES OF THE AIMING ARM LATCH FAILURE WERE IDENTIFIED. 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 FORM MANUFACTURING ISSUES NOT LEADING TO COMPLETE BOND BETWEEN THE CARBON LAYERS. DEVICE FAILURE/DEFECT IDENTIFIED: YES 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 AIMING ARM, RADIOLUCENT LATCH NO DESIGN ISSUE OR DISCREPANCY IS FOUND. COMPLAINT CONFIRMED? YES AS FRACTURE IS CONFIRMED THAT IS CONSISTENT WITH THE COMPLAINT CONDITION OF THE DEVICE. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE AIMING ARM/ RADIOLUCENT (PN: 03.043.029, LN: 2023566). THE ROOT CAUSE OF THE COMPLAINT CONDITION CAN BE CONFIRMED AS THE MANUFACTURING/PROCESSING ERROR WITH THE CARBON FIBER LAYERS. JNJ NONCONFORMANCE 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 THE NONCONFORMANCE. 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. G1: MANUFACTURING SITE NAME AND ADDRESS

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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) 2021, WHEN THE UNKNOWN TIBIAL NAIL WAS INSERTED AND THE AIMING ARM WAS CONNECTED AFTER, THE UNKNOWN TRIPLE SLEEVE AND UNKNOWN DRILL BIT WERE INSERTED BUT MISSED THE HOLE IN THE NAIL. THE BLACK TABS ON THE AIMING ARM WERE USED TO TIGHTEN DOWN THE AIMING ARM WHEN A LOUD CLICK HAPPENED. IT WAS ASSUMED IT WAS IN THE CORRECT POSITION BUT AFTER THE DRILL BIT STILL MISSED THE HOLE, IT WAS DISCOVERED THAT THE AIMING ARM WAS CRACKED ON ONE OF THE BLACK TABS. A NEW AIMING ARM REPLACED THE BROKEN ONE. THERE WAS A TEN MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384801 AIMING ARM/ RADIOLUCENT SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.043.029 2023566 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female 4.2MM TROCAR 210MM| AIMING ARM/ RADIOLUCENT| DRILL SLEEVE / 4.2MM| DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG| PROTECTION SLEEVE/ 11/8| TIBIAL NAIL-ADVANCED / 10 315 / STERILE| 4.2MM TROCAR 210MM| AIMING ARM/ RADIOLUCENT| DRILL SLEEVE / 4.2MM| DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG| PROTECTION SLEEVE/ 11/8| TIBIAL NAIL-ADVANCED / 10 315 / STERILE