BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    MDR report key: 11236167 · Received January 27, 2021

    Report

    Report Number
    2939274-2021-00500
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Report Date
    January 6, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H10 ADDITIONAL NARRATIVE: D11: ADDITIONAL CONCOMITANT DEVICE REPORTED. H3, H4, H6: DEVICE HISTORY LOT. PART: 03.168.013. LOT: 200081-X02. MANUFACTURING SITE: SELZACH. SUPPLIER: LEITNER AG. RELEASE TO WAREHOUSE DATE: 08. APRIL 2020. PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE (B)(4) IS FOR COMPLAINTS FOR WHICH A NON-MANUFACTURING RELATED PROBABLE CAUSE HAS BEEN IDENTIFIED NO MRE REVIEW REQUIRED. INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED THAT ON (B)(6) 2021, THE STERILE PROCESSING DEPARTMENT (SPD) STAFF NOTIFIED, WHEN CLEANING THE OUTER PROTECTION SLEEVE WAS DAMAGED. THE SALES CONSULTANT WAS NOT AWARE WHEN THE LAST SURGERY OCCURRED WITH THIS SET OR WHEN IT HAPPENED. CUTTER SLEEVE OS DENTED IN AT THE FAR END OF IT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. H6: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS (PART # 03.168.013 / LOT # 200081-X02) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE WAS FOUND TO BE DEFORMED/BENT INWARD. NO OTHER DEFECTS WERE OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT WAS IDENTIFIED. COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DISTAL TIP OF THE DEVICE WAS DEFORMED INWARD. NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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. 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

    OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE HAS BEEN 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) 2021, WHEN CLEANING THE OUTER PROTECTION SLEEVE, THE STERILE PROCESSING DEPARTMENT (SPD) STAFF FOUND THE SLEEVE TO BE DAMAGED. THE CUTTER SLEEVE WAS DENTED IN AT THE FAR END OF IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132689 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 200081-X02 10886982274441

    Patients

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