BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X36MM

    MDR report key: 15492804 · Received September 27, 2022

    Report

    Report Number
    0009613350-2022-00502
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    August 29, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505421
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE-FOREIGN-JAPAN. CONCOMITANT MEDICAL PRODUCTS: ITEM#:47-2486-052-40 LOT#:3076792 ITEM NAME#:ANN BLUNT TIP SCREW 4X52MM; ITEM#:47-2486-124-40 LOT#:3091457 ITEM NAME#:ANN CORT BONE SCREW 4 X 24MM; ITEM#:47-2486-124-40 LOT#:3078235 ITEM NAME#:ANN CORT BONE SCREW 4 X 24MM; ITEM#:47-2488-000-04 LOT#:3081960 ITEM NAME#:ANN WASHER SMALL; ITEM#:47-2488-010-00 LOT#:3091275 ITEM NAME#:AFFIXUS PH NL CAP 0MM; ITEM#:47-2486-034-40 LOT#:3078217 ITEM NAME#:BLUNT TIP SCREW, 4X34MM; ITEM#:47-2486-034-40 LOT#:3077767 ITEM NAME#:BLUNT TIP SCREW, 4X34MM; ITEM#:47-2496-161-09 LOT#:3083154 ITEM NAME#:PROXIMAL HUMERUS, LEFT, 9X160MM. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 -2022 -00497; 0009613350 -2022 -00500; 0009613350 -2022 -00501.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW BACKED OUT FROM ITS PROPER POSITION TWO WEEKS AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2045460 BLUNT TIP SCREW, 4X36MM ROD, FIXATION, INTRAMEDULLARY HSB ZIMMER SWITZERLAND MANUFACTURER GMBH N/A 3068458 00889024505421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10 NARRATIVE.