BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY POWERDRIVER P2

    MDR report key: 16884933 · Received May 8, 2023

    Report

    Report Number
    0001032347-2023-00158
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GEY
    UDI-DI
    00841036063504
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2023-00159, 0001032347-2023-00160. D10: ITEM# 50-1010; LOT# 133340, ITEM# 50-1010; LOT# 665630. G2: FOREIGN - EVENT OCCURRED IN JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6, NO PRODUCT WAS RETURNED. A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER PROVIDED PICTURES. THE PHOTOS SHOW DEBRIS INSIDE OF THE STERILE PACKAGING. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE PROVIDED WORK INSTRUCTIONS DURING MANUFACTURING. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION AT THE RECEIVING WAREHOUSE, THERE WAS DEBRIS FOUND IN THE STERILE PACKAGING. NO CUSTOMER OR PATIENT WAS INVOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860562 BATTERY POWERDRIVER P2 MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY BIOMET MICROFIXATION NI 133340 00841036063504

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose SEE NARRATIVE IN H10