BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMETN FOR TRAUMA RECON

    MDR report key: 2844872 · Received October 19, 2012

    Report

    Report Number
    8030965-2012-01087
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RETURNED TO SYNTHES (B)(4) FOR EVALUATION; UNKNOWN DATE. SYNTHES (B)(4) RECEIVED A DEMO/LOANER RECIPROCATING SAW ATTACHMENT, BATTERY HANDPIECE, POWER MODULE, AND LID FOR THE BATTERY HANDPIECE WITH A REPORT THAT WHILE BEING USED IN AN EVALUATION AT MT. CARMEL NEW ALBANY, THE RECIPROCATING SAW ATTACHMENT SHOT OFF THE BATTERY HANDPIECE. IT WAS NOTED THAT THE HANDPIECE WAS SET TO DRILL/REAM MODE INSTEAD OF SAW MODE AT THE TIME OF THE OCCURRENCE. SYNTHES (B)(4) EVALUATED THE DEVICES AND THE INVESTIGATION REPORT INDICATES THE FOLLOWING: RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED; WHEN THE DEVICES WERE ASSEMBLED TOGETHER AND TESTED IN DRILL/REAM MODE, THE ATTACHMENT IMMEDIATELY CAME OFF THE HANDPIECE. THIS IS INDICATIVE OF MISUSE OF THE DEVICE. THERE IS A WARNING LABEL ON THE RECIPROCATING SAW ATTACHMENT TO OPERATE THE ATTACHMENT IN SAW MODE ONLY, AND THE LABELING WAS OBSERVED TO BE IN GOOD CONDITION AND EASILY LEGIBLE. IN ORDER TO PREVENT A RECURRENCE, IT IS RECOMMENDED THE USER REVIEW THE DIRECTIONS FOR USE AND ALL LABELING PRIOR TO OPERATING THE DEVICES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSULTANT REPORTED: WHILE SETTING UP RECIPROCATING SAW ATTACHMENT: IT WAS COUPLED TO THE BATTERY HANDPIECE AND TURNED ON TO DRILL/REAM MODE INSTEAD OF SAW MODE, THE SAW ATTACHMENT SHOT ACROSS THE ROOM. THE EVENT OCCURRED WITH EVALUATION EQUIPMENT AND WAS ASSEMBLED IN THE SALES OFFICE, THERE WAS NO HOSPITAL, PT INVOLVEMENT. IT WAS NOTED THE POWER MODULE HAS ALREADY BEEN IDENTIFIED AS AN OLD DESIGN THAT WAS NOT UPGRADED. THIS IS 3 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECIPROCATING SAW ATTACHMETN FOR TRAUMA RECON RECIPROCATING SAW ATTACHMENT KTT SYNTHES GMBH 2324

    Patients

    Seq Age Sex Outcome Treatment
    1 RECIPROCATING SAW ATTACHMENT| LID F/BATTERY| BATTERY HANDPIECE| POWER MODULE