BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 7698282 · Received July 18, 2018

    Report

    Report Number
    2939274-2018-52951
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 25, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HST
    UDI-DI
    10886982196057
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 357.371; SYNTHES LOT: 5080339; SUPPLIER LOT: NA; RELEASE TO WAREHOUSE DATE: DECEMBER 02, 2003; MANUFACTURED BY SYNTHES BRANDYWINE; NO NONCONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 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

    THERE IS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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) 2018, DURING A PRE-INSERTION TESTING OF THE TROCHANTERIC FIXATION NAIL (TFN) NAIL, THAT THE DEVICES WERE NOT ALIGNING CORRECTLY. THE NAIL WAS CONNECTED TO THE INSERTION HANDLE, THEN THE AIMING ARM WAS ATTACHED ALONG WITH THE COMPRESSION NUT AND SLEEVES FOR A WIRE. IT WAS NOTICED THAT THE BUTTRESS COMPRESSION NUT AND AIMING ARM WERE MISALIGNED WITH THE NAIL. THE AIMING ARM WAS REMOVED AND A NEW SET WAS OPENED WHERE THE ALIGNMENT WAS ACCURATE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CONCOMITANT DEVICE: INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540198 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED HST WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5080339 10886982196057

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE: (B)(6) 2018