BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER

    MDR report key: 6110089 · Received November 17, 2016

    Report

    Report Number
    9680938-2016-10173
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    October 27, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE & REPAIR EVALUATION/REVIEW WAS ATTEMPTED; NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.820.129 WITH LOT NUMBER(S) T980139 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 27-SEP-2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. ADDITIONAL MANUFACTURE DATE IS 10-DEC-2012. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART MFG. 03.820.129, LOT#: T980139, DATE: MANUFACTURING DATE: 21-SEP-2012. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 20-SEP-2012. NO NCRS WERE GENERATED DURING PRODUCTION. SUBJECT DEVICE HAS BEEN RECEIVED AND A SERVICE HISTORY EVALUATION/REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE ITEM WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THAT ONE OF THE PINS IN THE HANDLE CAME OUT. LOOSE COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. NO PARTS WERE REPLACED. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 9-NOV-2016 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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

    SERVICE AND REPAIR REPORTED THAT SYNTHES EVALUATION EQUIPMENT FAILED INSPECTION. THE ITEM, AN IMPLANT INSERTER, WAS REPORTED AS BROKEN. ISSUE WAS IDENTIFIED DURING SERVICE & REPAIR ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER AND NO PATIENT OR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVED 1 PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760513 IMPLANT INSERTER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES TUTTLINGEN T980139

    Patients

    Seq Age Sex Outcome Treatment
    1