BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON 15MM DET.130DEG UP 180MM 6MM

    MDR report key: 6358944 · Received February 24, 2017

    Report

    Report Number
    9610612-2017-00107
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 16, 2017
    Report Date
    June 28, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    LRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. IT WAS REPORTED THAT THE DEFORMATION OF THE JAWS CAUSED THE DEVICE TO STICK DURING SURGERY. TOTAL OF TWENTY-THREE DEVICES WERE RETURNED TO THE MANUFACTURE WITH REPORT OF STICKING. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00046, 9610612-2017-00094, 9610612-2017-00095, 9610612-2017-00096, 9610612-2017-00097, 9610612-2017-00098, 9610612-2017-00099, 9610612-2017-00100, 9610612-2017-00101, 9610612-2017-00102, 9610612-2017-00103, 9610612-2017-00104, 9610612-2017-00105, 9610612-2017-00106, 9610612-2017-00108, 9610612-2017-00109, 9610612-2017-00110, 9610612-2017-00111, 9610612-2017-00112, 9610612-2017-00113, 9610612-2017-00114, 9610612-2017-00115.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY ATS, THE HARDNESS TEST BY MTI. SURFACE: LABELING TAPED AND SURFACE SANDBLASTED. SHAPE: DEVIATIONS DUE TO BAD MAINTENANCE, DAMAGED CUTTING EDGE GEOMETRY POSITION: OK. FUNCTION: GUIDING GEOMETRY DAMAGED, DAMAGED CUTTING EDGE GEOMETRY. DECOMPOSABILITY: OK. SCREW SEAT: OK. CUT FUNCTION: SUBOPTIMAL HARDNESS: 45,1 HRC (42+8 HRC). CONCLUSION: WEAR AND TEAR. BATCH HISTORY REVIEW THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. CORRECTIVE ACTION ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140044 KERRISON 15MM DET.130DEG UP 180MM 6MM BONE PUNCHES LRY AESCULAP AG FK975R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other