BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)

    MDR report key: 6803655 · Received August 18, 2017

    Report

    Report Number
    9612488-2017-10415
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    UDI-DI
    07611819201866
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED. REPORTED INSTRUMENT IS NOT DELIVERED IN ORIGINAL PACKAGING. THE TOOTHING DOES NOT EXIST: HAS BROKEN. LASER MARKING IS READABLE. A DEVICE HISTORY RECORD (DHR) CHECK WAS PERFORMED FOR THE AFFECTED PRODUCT COMPONENT (B)(4) / LOT 9870463. DURING THE LABELING AND PACKAGING PROCESS THIS ARTICLE HAS CHANGE ITS LOT AND PART NUMBER AS 309.038 / LOT 9935889. THE DHR HAS REVIEWED AND NO ISSUE OR DEVIATION WAS FOUND WHICH COULD LEAD TO THE COMPLAINT CONDITION. THE DIAMETERS WERE MEASURED AND MEET THE SPECIFICATION. ALL FEATURES MEASURED CORRESPOND TO THE PRODUCTION SPECIFICATIONS ACCORDING TO RELEVANT DRAWING. THE TOOTHING IS BROKEN IN THIS REGION (THIS PART OF THE ARTICLE IS MISSING). THE INTERNAL BORE HAS BEEN 100% TESTED AND DOCUMENTED ACCORDING TO THE INSPECTION SHEET. THE HARDNESS WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. THE LOTS OF THE RAW MATERIAL OF THE COMPONENT 36599 ARE NOT RACKED BY NUMBER. THEREFORE, THE CHECK WAS PERFORMED BASED ON FIFO (FIRST IN/FIRST OUT) BY INVESTIGATION OF THE RAW MATERIAL ORDERS, WHICH WAS CLOSEST TO THE START OF THE MANUFACTURING ORDER OF THE COMPONENT. THUS, IT WAS FOUND THAT USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. ON THE BASIS OF THE INVESTIGATION THE COMPLAINT IS CONFIRMED, SINCE THE PRODUCT WAS BROKEN IN A MANNER WHICH FITS TO THE DESCRIBED COMPLAINT CONDITION. HOWEVER, ACCORDING TO THE INVESTIGATION RESULTS THIS COMPLAINT IS RATED AS NOT VALID BECAUSE THE RELEVANT DIMENSIONS WERE MEASURED AND HAVE PASSED THE SPECIFICATIONS, BESIDES NO MANUFACTURING ISSUE COULD BE FOUND. 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

    IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT WITH THE BREAKAGE OF THE DEVICE. DATE OF EVENT REPORTED AS (B)(6) 2017. IT IS UNKNOWN IF THAT IS THE DATE THE DEVICE BROKE OR WAS DISCOVERED BROKEN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MAY 09, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE CUSTOMER RETURNED THE SPARE REAMER TUBE TO THE LOAN DEPARTMENT, IT WAS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583457 SPARE REAMER TUBE FOR HOLLOW REAMER (309.035) REAMER HTO SYNTHES BETTLACH 9870463 07611819201866

    Patients

    Seq Age Sex Outcome Treatment
    1