BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM

    MDR report key: 5611848 · Received April 27, 2016

    Report

    Report Number
    9680938-2016-10060
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 7, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE (1) 6MM DISC RONGEUR (PART 03.605.002, LOT T973401, MFG. 12/2011) WAS RECEIVED WITH A COMPLAINT STATING THAT THE DISTAL PORTION OF THE INSTRUMENT BROKE INTRA-OPERATIVELY. THE BROKEN PORTION WAS ABLE TO BE RETRIEVED AND ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY WITHOUT ANY DELAY. THE PART WAS EXAMINED UPON ARRIVAL AT CUSTOMER QUALITY. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS ABLE TO BE CONFIRMED AS THE MOVING CUP JAW WAS SHEARED OFF AT THE HINGE. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED BASED ON THE COMPLAINT DESCRIPTION; HOWEVER, IT IS LIKELY THAT EXCESSIVE FORCE, IMPROPER HANDLING, AND/OR THE AGE OF THE DEVICE (4+ YEARS) CONTRIBUTED TO THE COMPLAINT CONDITION. THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE UNDER THE SYSTEM RISK ASSESSMENT. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW - MANUFACTURING DATE: DEC 7, 2011. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. THE RAW MATERIALS WERE FOUND TO BE CORRESPONDING TO THE SPECIFICATIONS. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RONGEUR DEVICE BROKE AT THE DISTAL PORTION DURING A DISCECTOMY PROCEDURE ON (B)(6) 2016. IT WAS CONFIRMED THAT THE BROKEN PORTION OF THE DEVICE WAS RETRIEVED AND NO FRAGMENTS OR PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE SURGERY WITHOUT ANY TIME DELAY OR ANY FURTHER ISSUES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266953 DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM RONGEUR HTX SYNTHES TUTTLINGEN T973401

    Patients

    Seq Age Sex Outcome Treatment
    1