BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC OSTEOTOME 15MM/304MM

    MDR report key: 8951695 · Received August 30, 2019

    Report

    Report Number
    2939274-2019-60258
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    August 2, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWM
    UDI-DI
    10886982203113
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS A SYNTHES EMPLOYEE PART: 399.850, LOT: T123705: MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: SEPTEMBER 25, 2015. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH THE CUTTING SURFACE OF THE CHISEL DULL. THERE IS BLUNTING OF THE CUTTING EDGE DUE TO MULTIPLE USES. THE DISTAL TIP OF THE DEVICE SHOWS SIGNS OF WEAR. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE CHISEL IS WORN FROM REPEATED USE AND SERVICING. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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

    IT WAS REPORTED ON AUGUST 02, 2019, ONE (1) CURVED PELVIC OSTEOTOMY CHISEL, ONE (1) PELVIC OSTEOTOMY CHISELS, ONE (1) ANGLED PELVIC OSTEOTOMES AND ONE (1) BAYONET-SHAPED PELVIC OSTEOTOMES WERE NOTICED TO HAVE GOUGES AND FLATTENING OF THE CUTTING EDGES THROUGH INSPECTION. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A PELVIC OSTEOTOMY CHISEL. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745476 PELVIC OSTEOTOME 15MM/304MM OSTEOTOME HWM WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.85 T123705 10886982203113

    Patients

    Seq Age Sex Outcome Treatment
    1