BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6358952 · Received February 24, 2017

    Report

    Report Number
    9610612-2017-00105
    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; 9610612-2017-00106; 9610612-2017-00107; 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: DAMAGED CUTTING EDGE GEOMETRY. DECOMPOSABILITY: SUBOPTIMAL. SCREW SEAT: OK. CUT FUNCTION: BAD CUT DUE TO DAMAGED BLADE. HARDNESS: 46,0 HRC (42+8 HRC). CONCLUSION: INSUFFICIENT MAINTENANCE. 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 RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140051 KERRISON 15MM DET.130DEG UP 180MM 6MM BONE PUNCHES LRY AESCULAP AG FK975R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other