BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM X 4MM AUTO-DRIVE SCREW

    MDR report key: 15638953 · Received October 20, 2022

    Report

    Report Number
    2027754-2022-00051
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 12, 2022
    Report Date
    February 2, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    PMA / PMN Number
    K974785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING, AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE QUALITY CONTROL INSPECTION CONFIRMED THE REPORTED COMPLAINT AND IDENTIFIED THE SCREW AS A 211-1605 SCREW (5MM SCREW). A REVIEW OF THE AUTOMATED PACKAGING MACHINE LOG WAS PERFORMED. IT WAS CONCLUDED THE MOST LIKELY ROOT CAUSE OF THE INCORRECTLY PACKAGED PRODUCT WAS A FAILED LINE CLEARANCE ON THE AUTOMATED PACKAGING MACHINE AND OPERATOR OVERSIGHT IN THE PACKAGING INSPECTION. THE PACKAGING SUPERVISOR WAS NOTIFIED OF THE COMPLAINT. AN HHE WAS INITIATING AND IS PENDING REVIEW. A FOLLOW UP REPORT WILL BE SUBMITTED PENDING THE RESULTS OF THE HHE.

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR REPORTED THEY RECEIVED THREE (3) DIFFERENT BATCH/LOTS OF PART NUMBER 211-1604 SCREWS AND INSPECTED ALL THREE LOTS. AFTER THE INSPECTION OF ALL THREE LOTS, ONLY 1 SCREW (OUT OF 400 SCREWS) OF PART NUMBER 211-1604 SCREW IN BATCH/LOT 1173604 APPEARED TO BE 5MM IN LENGTH INSTEAD OF 4MM. AS PREVIOUSLY REPORTED THIS SCREW WAS RETURNED FOR EVALUATION. THE QUALITY CONTROL INSPECTION CONFIRMED THE REPORTED COMPLAINT AND IDENTIFIED THE SCREW AS A 211-1605 SCREW (5MM SCREW). A REVIEW OF THE AUTOMATED PACKAGING MACHINE LOG WAS PERFORMED. IT WAS CONCLUDED THE MOST LIKELY ROOT CAUSE OF THE INCORRECTLY PACKAGED PRODUCT WAS A FAILED LINE CLEARANCE ON THE AUTOMATED PACKAGING MACHINE AND OPERATOR OVERSIGHT IN THE PACKAGING INSPECTION. THREE HUNDRED AND THIRTY-NINE (339) PARTS OF 211-1604 LOT 1173604 REMAINED IN OSTEOMED INVENTORY FOR REVIEW AND WERE QUARANTINED .THE PARTS WERE 100% SORTED AND NO NONCOMFORMANCES (INCORRECTLY PACKAGED SCREWS) WERE IDENTIFIED. NONETHELESS, DUE TO THE POTENTIAL FOR A PART NUMBER 211-1605 SCREW (5MM) TO BE INCORRECTLY WITHIN PART NUMBER 211-1604 (4MM SCREW) PACKAGING, A RECALL IS BEING INITIATED FOR BATCH/LOT NUMBER: 1173604. THE TWO CONSIGNEES HAVE BEEN CONTACTED. THIS RECALL DOES NOT AFFECT THE UNITED STATES.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE DISTRIBUTOR REPORTED DURING THEIR RECEIVING INSPECTION OF PART NUMBER 211-1604 SCREWS (1.6MM X 4MM AUTO-DRIVE SCREW), THEY FOUND ONE SCREW THAT WAS 5MM IN LENGTH. THEY HAD NOT YET FINISHED THEIR INSPECTION OF PRODUCT AND WOULD PROVIDE AND UPDATE AFTER THEIR INSPECTION WAS COMPLETE. NO PATIENT WAS INVOLVED AS THIS ISSUE WAS NOTED DURING THEIR RECEIVING INSPECTION OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017041 1.6MM X 4MM AUTO-DRIVE SCREW SCREW, FIXATION, BONE HWC OSTEOMED, LLC 211-1604 1173604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown