BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIX BLADE 100MM

    MDR report key: 10395301 · Received August 12, 2020

    Report

    Report Number
    2939274-2020-03479
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    July 21, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982178268
    PMA / PMN Number
    K042895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE JDO. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION SUMMARY. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY PART NUMBER: 282.239. LOT NUMBER: H761050. PART MANUFACTURE DATE: 06-NOV-2018. MANUFACTURING LOCATION: (B)(4). PART EXPIRATION DATE: N/A. NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF HELIX BLADE 100MM PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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) 2020 THE PATIENT UNDERWENT REMOVAL OF DYNAMIC HELICAL HIP SYSTEM (DHHS) FOLLOWED BY CONVERSION OF TOTAL HIP REPLACEMENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DHHS SYSTEM ON AN UNKNOWN DATE. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS REPORT IS FOR A HELIX BLADE. (B)(4) IS LINKED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862969 HELIX BLADE 100MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 282.239 H761050 10886982178268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 130 DEG LCP® DHHS(TM) SIDEPLATE-4 HOLES| UNIVERSAL LOCKING TROCHANTER STAB. PLATE 131MM| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING