BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3010239 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01548
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, WHILE SURGEON WAS PLACING A JIG PIN DURING TPLO ON A CANINE, THE SMALL BATTERY DRIVE WAS MAKING A GRINDING NOISE AND THE DRILL WOULD NOT SPIN WHEN PRESSED UP AGAINST THE BONE. SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE AND THE CANINE WAS CLOSED AT THAT TIME. CANINE WAS RETURNED TO THE OR THE FOLLOWING DAY WHEN A NEW DRILL WAS OBTAINED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. CANINE IS REPORTED TO BE DOING WELL. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113324 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention