BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 6086215 · Received November 8, 2016

    Report

    Report Number
    9612488-2016-10451
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    October 18, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 351.16J WITH LOT NUMBER 8053605 IS A LOT/BATCH CONTROLLED ITEM. THE RELEASE TO WAREHOUSE DATE OF THIS ITEM IS SEP 12, 2012. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 351.16J WITH LOT # 8053605. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 05, 2012. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE AND REPAIR EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE ITEM CAME APART AND WOULD NOT STAY TOGETHER. THE REPAIR TECHNICIAN REPORTED THE CHUCK SLEEVE SCREW WAS MISSING, ONE OF THE CHUCK PINS WAS MISSING AND THE OTHER PIN WAS BROKEN. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CHUCK SLEEVE SCREW, CHUCK PIN (2). THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 14-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

    SYNTHES SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT A FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK CAME APART AND WILL NOT STAY TOGETHER. ADDITIONALLY, ONE SET SCREW IS IN PLACE AND THE OTHER IS MISSING. THE SALES CONSULTANT RELAYED THAT THE SET IS USED THREE TO FIVE TIMES A WEEK TO PUT NAILS IN. THE ISSUE WAS FOUND DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737731 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER HTO SYNTHES BETTLACH 8053605

    Patients

    Seq Age Sex Outcome Treatment
    1