BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCKNG/NEUTRAL GUIDE FOR 3.5MM VA-LCP PROX TIBIA AIMING ARM

    MDR report key: 7773494 · Received August 10, 2018

    Report

    Report Number
    2939274-2018-53272
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Report Date
    June 14, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982075109
    PMA / PMN Number
    K120689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. ADDITIONAL DEVICE PRODUCT CODE: HWC. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER IS SYNTHES SALES CONSULTANT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 03.127.010, LOT: 8251056: MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 28.MAY.2013: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE LOCKING/NEUTRAL GUIDE FOR 3.5 MM VA-LCP PROXIMAL TIBIA AIMING ARM (PART # 03.127.010, LOT # 8251056, MFG # 28-MAY-2013) WAS INSPECTED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT APPROXIMATELY 45% OF THE CIRCUMFERENCE OF THE DISTAL END OF THE LOCKING/NEUTRAL GUIDE WAS DEFORMED/ BENT. NO NEW ISSUES HAVE BEEN IDENTIFIED. THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO POST-MANUFACTURE DAMAGE OF LOCKING/NEUTRAL GUIDE. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWING(S) WAS REVIEWED; NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS LOCKING/NEUTRAL GUIDE WAS RECEIVED DEFORMED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DROPPED, STRUCK OFF-AXIS OR DAMAGED DURING USAGE OR HANDLING OR STERILE PROCESSING). BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 DURING A SET INSPECTION ON (B)(6) 2018, IT WAS NOTICED THAT THE TIP OF THREE (3) LOCKING/NEUTRAL GUIDES FOR 3.5 MM VARIABLE ANGLE-PERIARTICULAR PLATING PROXIMAL TIBIA AIMING ARM WAS DEFORMED AND BOTTOM WAS DAMAGED. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT APPROXIMATELY 45% OF THE CIRCUMFERENCE OF THE DISTAL END OF THE LOCKING/NEUTRAL GUIDE WAS DEFORMED/ BENT. THIS PRODUCT CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615317 LCKNG/NEUTRAL GUIDE FOR 3.5MM VA-LCP PROX TIBIA AIMING ARM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.127.010 8251056 10886982075109

    Patients

    Seq Age Sex Outcome Treatment
    1