BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT

    MDR report key: 11555890 · Received March 23, 2021

    Report

    Report Number
    2939274-2021-01488
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    March 23, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GAD
    UDI-DI
    10705034715759
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART NUMBER: 03.615.350, LOT NUMBER: T951371. MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: 29-OCT-2010. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE BLADE CRANIAL/CAUDAL LE L50 (P/N: 03.615.350, LOT NUMBER: T951371) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED A SMALL PIECE HAD BROKEN OFF ONE OF THE CORNERS. DEVICE FAILURE/DEFECT IDENTIFIED? YES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. THIS COMPLAINT IS CONFIRMED AS A SMALL PIECE HAD BROKEN OFF ONE OF THE CORNERS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE INSTRUMENT TIP WAS DAMAGED. THIS WAS NOTICED WHEN THE SETS WERE OPENED TO BE USED FOR SURGERY. IT HAD NO PATIENT IMPACT AS IS WAS NOT THE SIZE THE SURGEON NEEDED TO USE. THIS REPORT IS FOR ONE (1) RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447709 RETRACTOR BLADE 50MM CRANIAL/CAUDAL-LEFT RETRACTOR GAD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.615.350 T951371 10705034715759

    Patients

    Seq Age Sex Outcome Treatment
    1