BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE

    MDR report key: 2992887 · Received March 7, 2013

    Report

    Report Number
    2520274-2013-01337
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DESCRIBE EVENT OR PROBLEM: (B)(4) AND IS BEING RETRACTED.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A VETERINARY PROCEDURE ON (B)(6) 2013 WHILE A TIBIAL-PLATEAU-LEVELING OSTEOTOMY WAS PERFORMED THE OSCILLATING SAW ATTACHMENT CONSTRUCT WAS RUNNING INTERMITTENTLY AND A BROWNISH FLUID LEAKED FROM THE DEVICE. THE TIBIAL-PLATEAU-LEVELING OSTEOTOMY WAS SUCCESSFULLY COMPLETED USING ANOTHER ATTACHMENT. REPORTEDLY THERE WERE NO DELAYS IN THE SURGERY AND NO HARM TO THE PATIENT OR THE USER. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT IT IS A DUPLICATE OF (B)(4) FOR WHICH MEDWATCH # 8030965-2013-02358 WAS SUBMITTED. THEREFORE, THIS COMPLAINT IS BEING RETRACTED AND (B)(4) WILL REMAIN THE OFFICIAL COMPLAINT OF RECORD. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98091 OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE HWE SYNTHES USA 1222-R

    Patients

    Seq Age Sex Outcome Treatment
    1