BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 110MM - STERILE

    MDR report key: 8171065 · Received December 17, 2018

    Report

    Report Number
    2939274-2018-55424
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982098559
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ADDITIONAL NARRATIVE: DEVICE HISTORY LOT PART NUMBER: 04.038.110S. LOT NUMBER: 7920235. PART MANUFACTURING DATE: 09 MARCH 2015. MANUFACTURING SITE: ELMIRA. PART EXPIRATION DATE: 31 JANUARY 2025. NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7920235 OF TFNA SCREWS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 7818863 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS 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.

    Additional Manufacturer Narrative · 1

    EVENT DATE IS UNKNOWN DATE IN 2018. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. A REVIEW OF THE DEVICE HISTORY RECORDS 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, THE PATIENT UNDERWENT A REVISION SURGERY OF A LAG SCREW AND A TITANIUM CANNULATED TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) SHORT NAIL. IT WAS A 110 MM SCREW THAT COLLAPSED LATERALLY. PATIENT REPORTED ISSUES OF PAIN AND IRRITATION AT THE SIDE OF THE HIP AND TISSUE AREA. THE SCREW WAS REMOVED, AND THE SHORTER 90 MM SCREW WAS PUT IN PLACE. AFTER THE SURGERY, THE SURGEON VIEWED THE X-RAY FROM THE ORIGINAL SURGERY AND REPORTED HE STATICALLY LOCKED THE LAG SCREW ON THE ORIGINAL SURGERY TO PREVENT GUIDED COLLAPSE DUE TO THE REVERSE OBLIQUE FRACTURE PATTERN. THE TFNA AND SCREW WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. THERE WAS NO DELAY IN THE REVISION SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: TITANIUM CANNULATED TFNA (PART# 04.037.142S, LOT# H171125, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA SCREW 110MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010490 TFNA SCREW 110MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.110S 7920235 10886982098559

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE EVENT DESCRIPTION.