BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING SURGICAL PUNCH - FLAT TIP

    MDR report key: 15146228 · Received August 2, 2022

    Report

    Report Number
    0001032347-2022-00242
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZG
    UDI-DI
    10841291105206
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). DEVICE PRODUCT CODE - LRY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER A&E MEDICAL CORPORATION - (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THE HAIR COULD BE SEEN THROUGH THE PACKAGING, THEREFORE THE PACKAGE WAS NOT OPENED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430655 ROTATING SURGICAL PUNCH - FLAT TIP PUNCH, SURGICAL DZG BIOMET MICROFIXATION N/A 05038 10841291105206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown