BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT, 2.0MM, CANNULATED, LARGE MANUAL

    MDR report key: 14221067 · Received April 27, 2022

    Report

    Report Number
    2027754-2022-00009
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 27, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE DEVICE IS A REUSABLE INSTRUMENT AND WAS MANUFACTURED IN 2012; THEREFORE, IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED PRIOR TO THIS REPORTED COMPLAINT EVENT. FURTHERMORE, THE DEVICE WAS NOT RETURNED, SO AN EVALUATION COULD NOT BE PERFORMED. THIS IS THE ONLY REPORTED COMPLAINT IN THE LAST TWO (2) YEARS FOR THIS PART NUMBER. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. ONE (1) NCR WAS IDENTIFIED DURING DHR REVIEW OF THE REPORTED LOT NUMBER WHICH HAD A SORT AND SCRAP/REWORK DISPOSITION. EIGHTY-FIVE (85) UNITS WERE RELEASED TO INVENTORY ON 13 FEBRUARY 2012. NO OTHER ISSUES WERE IDENTIFIED DURING DHR REVIEW. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) INDICATED THE IFU INSTRUCTS THE USER TO INSPECT THE INSTRUMENTS BEFORE AND AFTER EACH PROCEDURE TO ASSURE THEY ARE IN PROPER OPERATING CONDITION AND TO NOT USE INSTRUMENTS WHICH ARE FAULTY, DAMAGED, OR SUSPECT. USERS ARE INSTRUCTED TO REPLACE THE INSTRUMENT AND CONTACT OSTEOMED FOR FURTHER INSTRUCTIONS REGARDING DISPOSITION OF THE PRODUCT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED ONE OF THE BLADE TIPS WAS BROKEN. FURTHERMORE, THE LASER MARKINGS ON THE DEVICE WERE FADED WHICH WAS INDICATIVE OF WEAR/USAGE. DESPITE THE BROKEN BLADE TIP, THE RETURNED DEVICE WAS INSPECTED BY QUALITY CONTROL PERSONNEL AGAINST THE INSPECTION PLAN. ALL FEATURES THAT COULD BE MEASURED WERE WITHIN SPECIFICATIONS. THE DEVICE IS A REUSABLE INSTRUMENT AND WAS MANUFACTURED IN 2012; THEREFORE, IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED PRIOR TO THIS REPORTED COMPLAINT EVENT. FURTHERMORE, THE RETURNED DEVICE WAS EVALUATED AND HAD A BROKEN BLADE TIP AND SHOWED SIGNS OF WEAR. THE FEATURES THAT COULD BE MEASURED MET SPECIFICATION PER THE INSPECTION PLAN (IP). FINALLY, THIS IS THE ONLY REPORTED COMPLAINT IN THE LAST TWO (2) YEARS FOR THIS PART NUMBER. BASED ON THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE 2.0MM DRIVER STEM (PART NUMBER 316-1120) BROKE. THE SCREW WAS REMOVED WITH A NEW DRIVER, AND A 2.0 X 20MM SCREW WAS PLACED INSTEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367013 SCREWDRIVER SHAFT, 2.0MM, CANNULATED, LARGE MANUAL SCREWDRIVER SHAFT HXX OSTEOMED, LLC 316-1120 1047354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown