BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    MDR report key: 6235701 · Received January 9, 2017

    Report

    Report Number
    9612488-2017-10013
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    UDI-DI
    10886982193742
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A SERVICE HISTORY REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE BUT COULD NOT BE COMPLETED BECAUSE THE DEVICE IS A BATCH/LOT CONTROLLED ITEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE: SEP 05, 2012. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    A SERVICE AND REPAIR EVALUATION WAS CONDUCTED ON THE SUBJECT DEVICE (FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK, PART # 351.16J, LOT # 8053605). THE CUSTOMER REPORTED THE ITEM FELL APART. THE REPAIR TECHNICIAN REPORTED THE CHUCK PIN WAS MISSING. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: CHUCK PIN. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 23-JAN-2017 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED FOR EVALUATION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONAL RELEASE TO WAREHOUSE DATES: 12-SEP-2012. 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 AFTER THE DEVICE WAS STERILIZED IT WAS FOUND THAT THE FLEXIBLE SHAFT CONNECTOR WAS UNABLE TO BE PROPERLY ASSEMBLED. IT APPEARS THAT A PIN THAT HOLDS THE SPRING IN PLACE IS MISSING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16034 FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER HTO SYNTHES BETTLACH 8053605 10886982193742

    Patients

    Seq Age Sex Outcome Treatment
    1