BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER RONGEUR CUP 2 X 6 MM STR 6IN

    MDR report key: 5035669 · Received August 3, 2015

    Report

    Report Number
    8010282-2015-00003
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 16, 2015
    Manufacturer
    WEBA MEDIZINTECHNIK GMBH & CO.
    Product Code
    HTX
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    A LAMINECTOMY IS A SURGICAL PROCEDURE THAT REMOVES A PORTION OF THE VERTEBRAL BONE CALLED THE LAMINA. THE BACK MUSCLES WERE PUSHED ASIDE RATHER THAN CUT AND THE PARTS OF THE VERTEBRAL ADJACENT TOT HE LAMINA ARE LEFT INTACT. ONLY THROUGH UNINTENDED USE BY CUTTING HARD TISSUE BONES, TEARING TISSUE APART BY TURNING THE JAW SIDEWAYS OR FAILED HARDENING A BREAKAGE COULD OCCUR. EACH LOT IS TESTED REGARDING HARDENING. SPECIFICATION OF HARDENING: 42-48HRC. MEASUREMENTS ARE RECORDED ON THE DHR. THERE WERE NO FAILURES IN THE HARDENING PROCESS DETECTED DURING MFR'G. THEREFORE FAILED HARDENING CAN BE EXCLUDED. DEVICE WAS NOT USED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    MEDICAL SPECIALITIES: BROKEN MEDWATCH REPORT STATED, "DURING BILATERAL LAMINECTOMIES AT L4-L5; LEFT MEDIAL FACETECTOMY AT L-4-L-5 AND DISCECTOMY AT L-4-L5, DECKER NEURO 2MM RONGEUR BROKE OFF INTO SURGICAL FIELD. SURGEON RECOVERED TIP W/NO RESULTING PATIENT INJURY SURGERY COMPLETED". ADD'L INFO RECEIVED FROM THE CUSTOMER ON 07/01/2015. PER THE CUSTOMER'S PROCEDURES, THE DEVICE WILL NOT BE RELEASED OFF-SITE UNTIL ANY APPLICABLE STATUTE OF LIMITATIONS HAS EXPIRED. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY TO A PATIENT OR HEALTHCARE PROFESSIONAL. IN ADDITION, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED DUE TO THE REPORTED ISSUE. THE BROKEN TIP DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS NOT DELAYED AS A RESULT OF THE REPORTED ISSUE. IT IS UNKNOWN IF THE DEVICE INSPECTED PRIOR TO SURGERY. THE DEVICE IS ONLY AVAILABLE FOR INVESTIGATION ONSITE. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. ADDITIONAL INFO RECEIVED FROM THE CUSTOMER ON JULY 7, 2015. THE CUSTOMER PROVIDED A FEW PICTURES OF THE COMPLAINT INSTRUMENT AND THE LOT NUMBER OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505671 DECKER RONGEUR CUP 2 X 6 MM STR 6IN NONE HTX WEBA MEDIZINTECHNIK GMBH & CO. NL6250 XWAI11

    Patients

    Seq Age Sex Outcome Treatment
    1 NI