BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 8843687 · Received July 30, 2019

    Report

    Report Number
    2939274-2019-59460
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Report Date
    June 7, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034771069
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS SYNTHES EMPLOYEE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: LOT NUMBER 1221134 INDICATES COMPONENT 50131166 WHICH IS A SUBCOMPONENT OF PART 387.337 AS DESCRIBED IN THE COMPLAINT. PART: 387.337. LOT: 1221134. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 02.FEB.2004. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: SYNFRAME HALF RING (PART # 387.337, LOT # 1221134) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE CONNECTING SCREW IS STUCK, AND THE LOCKING NUT IS SEVERELY DEFORMED CONSISTENT WITH USE. REST OF THE DEVICE SHOWS SCRATCHES AND WEAR CAUSED DUE TO REGULAR USE WHICH HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE NEEDS REPAIR. THE REPAIR TECHNICIAN REPORTED THE DEVICE IS DAMAGED. UNAUTHORIZED REPAIR IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE AND DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. THE DEVICE RECEIVED WITH A STUCK CONNECTING SCREW. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE SYNFRAME HALF RING (PART # 387.337, LOT # 1221134) IS RECEIVED WITH STUCK CONNECTING SCREW AND DEFORMED LOCKING NUT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE DEFORMATION/STUCK AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN INSPECTION AT THE LOANERS DEPARTMENT, IT WAS IDENTIFIED THAT THE SCREW OF THE SYNFRAME HALF RING NEEDS REPAIR. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE SCREW WAS STUCK. THIS REPORT IS FOR ONE (1) SYNFRAME HALF RING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637148 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 387.337 1221134 10705034771069

    Patients

    Seq Age Sex Outcome Treatment
    1