BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3777852 · Received April 29, 2014

    Report

    Report Number
    8030965-2014-10204
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE CUSTOMER DID NOT ALLEGE OR IDENTIFY ANY SPECIFIC DEFICIENCY; IT WAS OBSERVED DURING ROUTINE SERVICE AND REPAIR OF THE(LOT 002813) SMALL BATTERY DRIVE THAT IT RUNS INTERMITTENTLY. THE (ECU) ELECTRONIC CONTROL UNIT IS MOST LIKE DAMAGED FROM NORMAL USE OVER TIME. 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. THE MANUFACTURE DATE OF THIS ITEM IS 12-NOV-2007. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE IN DOCUSPHERE. 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 IT WAS DISCOVERED DURING AN ADDITIONAL EVALUATION THAT THE SMALL BATTERY DRIVE RUNS INTERMITTENTLY. IT WAS STATED THAT THIS CONDITION IS LIKELY DUE TO AN ELECTRICAL COMPONENT FAILURE DUE TO USAGE WEAR OVER TIME. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257510 SMALL BATTERY DRIVE INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 002813

    Patients

    Seq Age Sex Outcome Treatment
    1