BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATED ECCENTER EXTRACTOR F/GUIDE B

    MDR report key: 3231270 · Received July 17, 2013

    Report

    Report Number
    8030965-2013-04385
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS COORDINATED BY SYNTHES (B)(4) AND THE REPORT STATES THE FOLLOWING: THE INVESTIGATION OF THE COMPLAINT ECCENTER EXTRACTOR HAS SHOWN THAT THE TIP OF THE STRAIGHT CLAW BROKEN OFF. THE MEASURABLE DIMENSIONS OF THE INSTRUMENT WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. FURTHER, ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED ON WHAT LED TO THIS OCCURRENCE, THE CAUSE OF FAILURE IS MOST LIKELY THE RESULT OF THE ECCENTER EXTRACTOR WAS NOT MOUNTED CORRECTLY ON THE IMPLANT. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE INSTRUMENT WAS MANUFACTURED IN JULY 2010 ACCORDING TO THE SPECIFICATIONS. THE SURFACE OF THE CROSS-SECTION IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE EXTRACTOR BROKE DURING SURGERY ON AN UNKNOWN DATE. THERE WAS NO HARM TO THE PATIENT OR SURGEON. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330659 ARTICULATED ECCENTER EXTRACTOR F/GUIDE B HWB SYNTHES GMBH 10-0419

    Patients

    Seq Age Sex Outcome Treatment
    1