BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM

    MDR report key: 14877260 · Received June 30, 2022

    Report

    Report Number
    9610612-2022-00160
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 8, 2022
    Report Date
    October 13, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 - SERIAL NUMBER. D9 - PRODUCT RETURN. INVESTIGATION: WE DID RECEIVE THE HANDPIECE FOR INVESTIGATION. THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE HANDPIECE WITH THE SERIAL NUMBER 2018-1002961 (LOT UNKNOWN) WAS MANUFACTURED IN 2018. IN OUR SAP SYSTEM WE COULD NOT FOUND THAT THE PRODUCT HAD MAINTENANCE PERFORMED. DUE TO THE LONG USE SINCE 2018, THE PRODUCT HAS BEEN WORN OUT ACCORDINGLY AND IS IN POOR CONDITION. THE ANALYSIS WAS BE DONE ACCORDING TO THE SERVICE MANUAL VERSION 2.0. THE RESULTS ARE AS FOLLOWS: THERE IS A STRONG HEAT DEVELOPMENT. HANDPIECE TESTED BY 30 000 1/MIN - 3 MINUTES ENDURANCE RUN - TEMPERATURE 44,5°. HANDPIECE TESTED BY 40 000 1/MIN - 3 MINUTES ENDURANCE RUN - TEMPERATURE 71,1°. ADDITIONALLY IT WAS DETECTED THAT THE BALL BEARING IS DEFECTIVE AND WITH RESIDUES. FURTHERMORE THE BEVEL PINION IS WORN. THEREFORE, WE RECOMMEND THAT THE PRODUCT UNDERGO MAINTAINANCE AT LEAST ONCE A YEAR. ADDITIONALLY, THERE CAN BE RISK OF BURNS CAUSED BY BLUNT TOOLS OR INADEQUACY OF MAINTENANCE AS PER THE INSTRUCTIONS FOR USE (IFU). BATCH HISTORY REVIEW: DUE TO THE FACT THAT A LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 6(10) X PROBABILITY OF OCCURRENCE 3(10)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY REPROCESSING RELATED AND LACK OF MAINTENANCE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GD455M - MICRO-LINE ANGLED HDPC 1:2 F/ 2.35 X 70 MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP GENERATED HEAT. THIS OCCURRED DURING A TOOTH EXTRACTION SURGERY ON (B)(6) 2022. THERE WAS TEMPORARY IMPAIRMENT. A BURN WAS FOUND AT THE LOWER RIGHT CORNER OF THE MOUTH. 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
    2015580 MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM HIGHSPEED POWER SYSTEMS HWE AESCULAP AG GD455M

    Patients

    Seq Age Sex Outcome Treatment
    1 Female