BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 9298291 · Received November 8, 2019

    Report

    Report Number
    2939274-2019-62054
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Report Date
    September 9, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART: 314.291, LOT: 160466-401, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(6), RELEASE TO WAREHOUSE DATE: MARCH 01, 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SLIDING MECHANISM WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE INTERNAL THREADS OF THE SHAFT WERE STRIPPED AND THE SYNTHES SCREENING IS MISSING. THERE WERE SCRATCHES AND DISCOLORATION WHICH HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. FUNCTIONAL TEST: FUNCTIONAL TEST WAS PERFORMED AT SERVICE AND REPAIR EVALUATION. INSTRUMENT OPERATION TO BE SMOOTH AND NON-BINDING THROUGH ENTIRE RANGE OF OPERATION FAILED DURING FUNCTIONAL TEST. THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICE. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE SLIDING MECHANISM WAS TOO TIGHT. THE REPAIR TECHNICIAN REPORTED THE DEVICE SHAFT WAS DAMAGED AND WAS MISSING A PART. DAMAGED COMPONENT 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 DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED: COLLINEAR REDUCTION CLAMP. ZUSTELLSTAB. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE SLIDING MECHANISM AS THE INTERNAL THREADS OF THE SHAFT ARE STRIPPED; THIS COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE FOR MISSING COMPONENTS COULD BE DUE TO STERILIZATION AND DEVICE USE. 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, A SLIDING MECHANISM WAS TOO TIGHT. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS TWISTED/BENT. THIS REPORT IS FOR A SLIDING MECHANISM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095458 SLIDING MECHANISM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.291 160466-401 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1