BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEARDROP HANDLE, AO COUPLING IMPLANT EXTRACTION SE

    MDR report key: 2634073 · Received June 21, 2012

    Report

    Report Number
    9610622-2012-00271
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1806-6173 CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 5 MM LOT# K402389; 1806-6172 CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM LOT# K954836.

    Description of Event or Problem · 1

    THE SALES REP, REPORTED THAT WHEN THE SURGEON TRIED TO CONNECT THE CONICAL EXTRACTOR ONTO THE TEARDROP HANDLE, THE DEVICES JAMMED TO EACH OTHER AND COULD NOT BE REMOVED. THE SALES REP ADDED THAT THE CUSTOMER PUT THE DEVICES IN A VICE TO TRY AND SEPARATE THEM BUT THEY WERE UNABLE TO DO SO. THE SALES REP REPORTED THAT THIS DID OCCUR DURING SURGERY AND THAT ANOTHER KIT WAS REQUIRED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. TWO HANDLES ARE BEING RETURNED UNDER THIS PER, BOTH OF WHICH REMAIN FIXED ONTO CONICAL EXTRACTORS. THE SALES REP CONFIRMED THAT THERE WAS NO DELAY TO SURGERY, AS A REPLACEMENT DEVICE BECAME AVAILABLE ALMOST IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEARDROP HANDLE, AO COUPLING IMPLANT EXTRACTION SE INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K403253 K605411

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other