BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDFORM-WURZELHEBER 623/74

    MDR report key: 11986775 · Received June 11, 2021

    Report

    Report Number
    9610612-2021-00469
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Report Date
    June 11, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE TIP OF THE PRODUCT IS BROKEN OFF. THE BROKEN TIP WAS NOT PROVIDED FOR INVESTIGATION. THE FRACTURE SURFACE IS VERY SMALL THEREFORE A CLEAR FRACTURE ANALYSIS IS NOT POSSIBLE. THERE ARE HINTS WHICH INDICATE A FORCED FRACTURE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. EXPLANATION AND RATIONALE THERE ARE NO HINTS FOR A MATERIAL OR MANUFACTURING PROBLEM. WE ASSUME THAT THE TIP OF THE DEVICE BROKE DUE TO AN OVERLOAD SITUATION. CONCLUSION AND ROOT CAUSE DUE TO THE CURRENT DEVIATION AND ACCORDING TO RATIONALE, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE-RELATED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH XA167R - HANDFORM-WURZELHEBER 623/74. ACCORDING TO THE COMPLAINT DESCRIPTION, THE WORKING END BROKE OFF DURING TOOTH EXTRACTION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT AVAILABLE. 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
    877961 HANDFORM-WURZELHEBER 623/74 ROOT ELEVATORS EMJ AESCULAP AG XA167R

    Patients

    Seq Age Sex Outcome Treatment
    1