BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3192595 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03837
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS OF THE HOUSING WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS DEVICE HISTORY REVIEW IS INDETERMINATE AS THE PROVIDED PART/LOT COMBINATION IS INCORRECT AND BECAUSE THE HISTORY OF THE MACHINE IS UNKNOWN AT SYNTHES (B)(4) AS THIS IS DOCUMENTED IN THE LOCAL SERVICE CENTER. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO THE COMPLAINT NOT MEETING THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #: 2520274-2013-03837.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2013, THE SMALL BATTERY DRIVE WOULD NOT RUN. IT IS REPORTED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 2-3 MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. THE SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292438 SMALL BATTERY DRIVE HWE SYNTHES USA 003804

    Patients

    Seq Age Sex Outcome Treatment
    1