BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASING FOR 14.4V BATTERY

    MDR report key: 3685297 · Received March 18, 2014

    Report

    Report Number
    8030965-2014-10039
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    February 21, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS A POWER TOOL/INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION CAN BE DRAWN, AS THE PRODUCT IS 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. 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. ADDITIONAL NARRATIVE: THE REPORTER'S COMPLAINT THAT THE ((B)(4)) BATTERY CASING HAS A BROKEN TIP WAS CONFIRMED. THE UNIT WAS EVALUATED AND WAS FOUND TO HAVE BROKEN PRONGS. THIS IS MOST LIKELY DUE TO IMPROPER HANDLING. 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 ON (B)(6) 2014 THAT THE FACILITY PURCHASING MANAGER ADVISED THE TIP OF THE SMALL BATTERY DRIVE CASING (PART #532.032, LOT # 001872) BROKE OFF. NO REPORT OF HARM TO PATIENT OR PROCEDURE NOTE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORTED EVENT INCLUDES ONE POWER DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160611 CASING FOR 14.4V BATTERY BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES OBERDORF 001872/4992206

    Patients

    Seq Age Sex Outcome Treatment
    1