BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE RADIOLUCENT INSERTION HANDLE

    MDR report key: 11485974 · Received March 15, 2021

    Report

    Report Number
    2939274-2021-01311
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 16, 2021
    Report Date
    February 16, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4: LOT, UDI, AND CATALOG. D9. G1: MANUFACTURING SITE NAME AND ADDRESS. G4. H3, H4, H6: PART: 03.037.012, LOT: 9921264, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JUNE 21, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE COMPLETE RADIOLUCENT INSERTION HANDLE (P/N: 03.037.012, LOT NUMBER: 9921264) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED IT WAS STUCK AND UNABLE TO BE DISASSEMBLED FROM THE RETURNED MATING DEVICES. NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE AND THE TWO RETURNED MATING DEVICES. THE DEVICES WERE UNABLE TO BE DISASSEMBLED FROM EACH OTHER. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO INACCESSIBILITY OF RELEVANT COMPONENT DIMENSIONS. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE CANNOT BE DISASSEMBLED FROM THE RETURNED MATING DEVICES. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. B5 D1, D2A, D2B.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, WHILE THE SURGEON WAS IMPLANTING PROXIMAL FEMORAL NAILING SYSTEM (TFNA), WHEN TRYING TO DRIVE THE UNKNOWN HELICAL BLADE TO THE TFNA NAIL, IT DID NOT ADVANCE AND PASS THE TFNA NAIL. THE SURGEON COULD NOT BACK OFF THE SET SCREW OR GET THE INSERTION HANDLE OFF WITH THE NAIL. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) COMPLETE RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN HANDLE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN. UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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. 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) 2021, WHILE THE SURGEON WAS IMPLANTING PROXIMAL FEMORAL NAILING SYSTEM (TFNA), WHEN TRYING TO DRIVE THE UNKNOWN HELICAL BLADE TO THE TFNA NAIL, IT DID NOT ADVANCE AND PASS THE TFNA NAIL. THE SURGEON COULD NOT BACK OFF THE SET SCREW OR GET THE INSERTION HANDLE OFF WITH THE NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383354 COMPLETE RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9921264

    Patients

    Seq Age Sex Outcome Treatment
    1 11MM/130 DEG TI CANN TFNA 170MM - STERILE| UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - SCREWS: LOCKING