BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE RADIOLUCENT INSERTION HANDLE

    MDR report key: 8386397 · Received March 4, 2019

    Report

    Report Number
    2939274-2019-56770
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 9, 2019
    Report Date
    February 9, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982070289
    PMA / PMN Number
    K131548
    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. H3, H6: PART: 03.037.012; LOT: 9921272; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: JULY 26, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE TFNA NAIL IS STUCK TO THE INSERTION HANDLE. NO NEW MALFUNCTION WAS IDENTIFIED. RECEIVED CONDITION AGREES WITH COMPLAINT DESCRIPTION. FUNCTIONAL TEST: FUNCTIONAL TEST WAS NOT PERFORMED BECAUSE TFNA NAIL IS STUCK WITH INSERTION HANDLE. SEPARATION OF THE DEVICES WAS ATTEMPTED UNSUCCESSFULLY. REPLICATION OF THE COMPLAINT CONDITION IS ABLE TO BE REPLICATED. DIMENSIONAL ANALYSIS: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO RECEIVED CONDITION OF THE DEVICE. DOCUMENT INSPECTION: THE FOLLOWING DOCUMENTS WERE REVIEWED: - INSERTION HANDLE DRAWING A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NONCONFORMANCE REPORTS (NCRS), MANUFACTURER REVIEW REPORTS (MRRS), OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ALSO, BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT ANY ISSUES WITH MATERIAL OR MATERIAL PROPERTIES CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THIS COMPLAINT IS CONFIRMED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE DURING ITS USAGE OR HANDLING COULD HAVE LED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. UPDATED EVENT INFORMATION. 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 · 0

    ON 04/09/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019 DURING A LEFT HIP INTRAMEDULLARY NAILING SURGERY, THERE WAS A SHORT TFNA NAIL THAT BECAME STUCK ON AN INSERTION HANDLE. THE T-HANDLE BALL HEX SCREWDRIVER WAS BENT WHILE TRYING TO REMOVE THE TFNA NAIL FROM THE RADIOLUCENT INSERTION HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FORTY-FIVE (45) MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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) 2019, THE PATIENT UNDERWENT A LEFT HIP INTERMEDULLARY NAILING SURGERY. THERE WAS A SHORT TFNA NAIL THAT BECAME STUCK ON A INSERTION HANDLE DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FORTY-FIVE (45) MINUTE DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) COMPLETE RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181396 COMPLETE RADIOLUCENT INSERTION HANDLE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.012 9921272 10886982070289

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR