BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING/CUTTING PLIERS

    MDR report key: 10880013 · Received November 20, 2020

    Report

    Report Number
    2939274-2020-05257
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Report Date
    October 27, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTC
    UDI-DI
    10886982198525
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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, H4, H6: PART 391.962, LOT T183337: MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: OCTOBER 30, 2019. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT THE CARBIDE INSERT WAS MISSING ON THE CUTTING SLOT OF THE DEVICE. NO OTHER VISUAL DAMAGES WERE OBSERVED ON THE DEVICE EXCEPT NORMAL WEAR. THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE DEVICE WAS MISSING A COMPONENT, BUT NO VISUAL BREAKAGES WERE OBSERVED ON THE DEVICE. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED DEVICE AS IT WAS MISSING A COMPONENT. THE ALLEGED BROKEN/DAMAGE CONDITION CANNOT BE CONFIRMED AS NO VISUAL BREAKAGES WERE OBSERVED ON THE DEVICE. 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. 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

    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 THE BENDING/CUTTING PLIERS WERE FOUND IN THE CENTRAL PROCESSING DEPARTMENT DAMAGED. ONE OF THE CARBON FIBER PIECES IN THE CUTTING PORTION OF THE PLIERS IS MISSING. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339272 BENDING/CUTTING PLIERS PLIERS, SURGICAL HTC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 391.962 T183337 10886982198525

    Patients

    Seq Age Sex Outcome Treatment
    1