BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE 7 F/INSERTION INSTR

    MDR report key: 11388725 · Received February 26, 2021

    Report

    Report Number
    2939274-2021-01082
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Report Date
    February 4, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GEA
    UDI-DI
    10886982274441
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE PROTECTION SLEEVE Ø7 F/INSERTION INSTR (PART # 03.168.013; LOT # 190512-701) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT THE DISTAL END OF THE DEVICE WAS BENT INWARD. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED BY ASSEMBLING THE DEVICE WITH THE FEMORAL NECK SYSTEM INSERTION HANDLE (P/N: 03.168.008, LOT NUMBER: 200155-101). BOTH DEVICES ASSEMBLED CORRECTLY WITHOUT ISSUE DESPITE THE PHYSICAL DEFECT AT THE DISTAL TIP. THE COMPLAINT CAN NOT BE REPLICATED WITH THE RETURNED DEVICE. NO FUNCTIONAL ISSUE WAS DETECTED DURING THE ASSEMBLY PROCESS. THE COMPLAINT IS CONFIRMED. INVESTIGATION CONCLUSION: THERE WAS NO DEVICE ISSUE REPORTED AND THE FUNCTIONAL TESTING WAS PERFORMED WITH NO ISSUE BY ASSEMBLING THE DEVICE WITH THE FEMORAL NECK SYSTEM INSERTION HANDLE. ONLY THE VISUAL INSPECTION REVEALED DEFORMATION AT THE DISTAL TIP OF THE DEVICE. NO ROOT CAUSE COULD DEFINITELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 03.168.013, LOT: 190512-701, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: MAY 04, 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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 AN UNKNOWN DATE, PATIENT UNDERWENT ORIF OF FEMORAL NECK PROCEDURE FOR UNKNOWN REASON. THERE WAS SURGICAL DELAY OF 15 MINUTES. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) PROTECTION SLEEVE Ø7 F/INSERTION INSTR. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280521 PROTECTION SLEEVE 7 F/INSERTION INSTR CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 190512-701 10886982274441

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR