BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LID FOR BATTERY HANDPIECE LID FOR BATTERY HANDPIECE

    MDR report key: 4092917 · Received September 16, 2014

    Report

    Report Number
    3009450871-2014-10401
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 19, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED (MIA). THE REPORT INDICATES THAT THE: LID 05.001.227 SN: (B)(4) FOR TRS MODULAR HAND PIECES WERE INSPECTED ON 13.01.2015. ALL TESTING WAS PERFORMED ACCORDING TO TEST AND TROUBLESHOOTING COMPATIBILITY ACCORDING TO COMPLAINT CONDITION WAS TESTED WITH THREE DIFFERENT TRS MODULAR HAND PIECES. THE LID PASSED ALL TESTING AND WAS LUBRICATED. THE ALLEGED "THE LID IN QUESTION WAS TOO TIGHT TO LOCK/UNLOCK." REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. IF HANDLING DIFFICULTIES DO STILL APPEAR AT CUSTOMER SITE, INVESTIGATION OF THE HAND PIECE IS REQUIRED, IT MAY BE DEFORMED. THIS INVESTIGATION IS UNCONFIRMED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE LID FOR THE BATTERY HAND-PIECE MODULAR SYSTEM WAS TOO TIGHT TO LOCK/UNLOCK. ANOTHER LID WAS USED INSTEAD AND IT WAS ALSO TIGHT ALTHOUGH THE SURGEON MANAGED TO USE THE SECOND LID AND COMPLETE THE OPERATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573064 LID FOR BATTERY HANDPIECE LID FOR BATTERY HANDPIECE BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1