BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON DETACH.130DEG UP 200MM 3MM THIN

    MDR report key: 11308943 · Received February 10, 2021

    Report

    Report Number
    9610612-2021-00083
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 18, 2021
    Report Date
    September 8, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GXJ
    UDI-DI
    04038653436880
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: LEADING DEVICE: REFERENCE CODE (B)(4). DEVICE NAME KERRISON DETACH.130DEG UP 200MM 3MM THIN. SERIAL NUMBER. BATCH NUMBER 52615085. MANUFACTURING DATE 10.09.2020. PRODUCT IS AVAILABLE FOR INVESTIGATION IN A DECONTAMINATED CONDITION. FAILURE DESCRIPTION: THE KERRISON PUNCH SHOWS A BENT-UP CUTTING EDGE ON THE UPPER SLIDER PART. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE PUNCH SHOWS A DEFORMATION ON THE CUTTING EDGE OF THE UPPER SLIDER, WHICH IS BENT-UP IN. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER WITH THIS ERROR PATTERN. EXPLANATION AND RATIONALE: THE FAILURES FOUND IN OUR INVESTIGATION ARE CLEAR SIGNS OF AN OVERLOAD SITUATION DURING THE PROCEDURE ITSELF. WE WERE NOT ABLE TO DETECT ANY HINT FOR A MATERIAL DEFECT OR A PRODUCTION ERROR. CONCLUSION AND ROOT CAUSE: DUE TO THE CURRENT DEVIATION AND ACCORDING TO THE EXPLANATION AND RATIONALE, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE-RELATED. A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP INC. THAT A (B)(4) (PART # FK963R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE DEVICE TIP WAS CURLED UP/BENT, FOLLOWING USE. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208291 KERRISON DETACH.130DEG UP 200MM 3MM THIN BONE PUNCHES, RONGEURS GXJ AESCULAP AG FK963R 52615085 04038653436880

    Patients

    Seq Age Sex Outcome Treatment
    1