BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3667680 · Received March 7, 2014

    Report

    Report Number
    8030965-2014-10024
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS A POWER TOOL AND NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED;NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SERVICE HISTORY RECORD/S AND ADDITIONAL POWER TOOL EVALUATION HAS BEEN REQUESTED 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: POWER TOOL EVALUATION WAS COMPLETED FOR THIS DEVICE. THE CUSTOMER'S COMPLAINT THAT THE ((B)(4)) SMALL BATTERY DRIVE HAS LOW POWER COULD NOT BE CONFIRMED. THE DEVICE WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS. 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

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(4) 2014 BY THE CONSULTANT THAT THE FACILITY OR PURCHASING COORDINATOR ADVISED THAT FOUR 532.010 (SMALL BATTERY DRIVES) WITH THE FOLLOWING LOT NUMBER 001050), 002761, 002535,002994 ) HAVE BEEN OBSERVED AS HAVING LOW POWER. NO REPORT OF PATIENT OR PROCEDURE HARM NOTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT EVENT IS FOR ONE POWER DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139505 SMALL BATTERY DRIVE INSTRU,SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 1050/4764303

    Patients

    Seq Age Sex Outcome Treatment
    1