BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 2974911 · Received February 22, 2013

    Report

    Report Number
    8030965-2013-00610
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE AS IT IS NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. MANUFACTURING EVALUATION REVIEWED, MDR REPORTABILITY STATUS UPDATED PER PMRM AND FS-932. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT # 8030965-2013-00610. PLACEHOLDER.

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTION: SYNTHES IS RETRACTING MEDWATCH REPORT # 8030965-2013-00610; MEDWATCH # (B)(4), MFG. # 8030965-2013-00610 WAS INADVERTENTLY LAUNCHED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, DURING AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT PILON FRACTURE, A SMALL BATTERY DRIVE WAS HEATING UP AND BURNING THE BONE. SURGEON STATED THAT THERE WAS NO VISUAL BURN TO THE BONE, BUT HE COULD SMELL SOMETHING BURNING. IT IS REPORTED THAT DURING THE SAME PROCEDURE, A SMALL PIECE OF DRILL BIT BROKE OFF DURING DRILLING, PRIOR TO INSERTING THE K-WIRE AND THE SURGEON WAS UNABLE TO RETRIEVE IT. SURGEON USED A BULB SYRINGE TO IRRIGATE DURING SURGERY. THE LOT NUMBER AND PRODUCT NUMBER IS UNKNOWN AS THE PRODUCT WAS DISPOSED OF AND IT IS UNKNOWN WHETHER OR NOT THE DRILL BIT WAS A SYNTHES PRODUCT. SURGERY WAS COMPLETED USING A COMPETITORS DRILL WITHOUT INCIDENT. THERE WAS NO DELAY IN SURGERY. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79060 QUICK COUPLING FOR K-WIRES QUICK COUPLING FOR K-WIRES HRS SYNTHES GMBH 07437

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR