BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    MDR report key: 9801146 · Received March 6, 2020

    Report

    Report Number
    2939274-2020-01175
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Report Date
    February 10, 2020
    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
    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: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS (PART # 03.168.013 / LOT # 180242-301) WAS RECEIVED AT US CQ. THE DISTAL TIP OF THE DEVICE WAS DEFORMED INWARD. THERE WERE SEVERAL SMALL CRACKS ALONG THE CIRCUMFERENCE OF THE TIP. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED. YES; DISTAL TIP WAS DEFORMED INWARD AND THERE WERE CRACKS ALONG THE TIPS CIRCUMFERENCE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED ITS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES. 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 PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.168.013. LOT: 180242-301. MANUFACTURING SITE: SELZACH. SUPPLIER: LEITNER AG. RELEASE TO WAREHOUSE DATE: 07.DECEMBER 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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 · 0

    FURTHER IT WAS REPORTED THAT THE SLEEVE WAS BENT.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. 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 AN UNKNOWN DATE, DURING AN INSPECTION OF THE INSTRUMENTS, A PROTECTION SLEEVE WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266739 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 180242-301 10886982274441

    Patients

    Seq Age Sex Outcome Treatment
    1 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS