BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CENTER SCREW 25MM

    MDR report key: 18887444 · Received March 12, 2024

    Report

    Report Number
    3002788818-2024-00033
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 2, 2024
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HSD
    UDI-DI
    00885556813577
    PMA / PMN Number
    K220847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE UNSATISFACTORY EXPERIENCE COULD BE CONFIRMED. DEVICE BATCH NUMBER WAS NOT PROVIDED, THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS 12 MONTHS DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE SIZE SELECTED OR INSERTION TECHNIQUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). SECTION B5 DESCRIBES THE MALFUNCTION OF 2 DEVICES: 4.5MM CENTER SCREW 25MM / PN: SCW-0990-507-25 - COVERED IN (B)(4). 4.5MM CENTER SCREW 30MM / PN: SCW-0990-507-30 - COVERED IN (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY SURGERY, A 4.5MM CENTER SCREW 25MM WAS INITIALLY USED BUT FAILED TO ACHIEVE COMPRESSION OF THE FAR CORTEX. THE 25MM SCREW WAS THEN BACKED OUT, THE BONE WAS REDRILLED AND A 4.5MM CENTER SCREW 30MM WAS SELECTED. THE SCREW SPUN, BUT DID NOT RECEIVE PURCHASE OF THE FAR CORTEX OF THE GLENOID VAULT RESULTING IN LOSS OF COMPRESSION. THE 30 MM SCREW WAS LEFT IN THE CONSTRUCT AND THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909784 4.5MM CENTER SCREW 25MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD ASCENSION ORTHOPEDICS, INC. UNKNOWN 00885556813577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GBP-0990-500-2 / GLENOID BASEPLATE CENTERED.