MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; BONE FIXATION SCREW/PLATE

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that an after building an mgs baseplate and central screw, the baseplate would not connect to the inserter.It appears that the baseplate does not have the threads in the central hub, as usual, making it impossible for the inserter to thread into the baseplate.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 06/25/2025: this occurred during an rtsa revision procedure on (b)(6) 2025.The inserter used in the case was the ar-9623 baseplate inserter.The case was completed by opening a new baseplate and central screw, ar-9560-24-2 24mm +2 lat baseplate, modular (lot: 15400885) and ar-9561-30s 30mm central screw, modular (lot: 15405212).The case was delayed five minutes, and whether additional anesthesia was administered is uncertain.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the cause for the reported failure is related to the mating part ar-9560-24-2.Refer to ncr-30892 for details.No issues were found for ar-9561-30s.

• Brand Name: 30MM CENTRAL SCREW, MODULAR
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22462188
• Report Number: 1220246-2025-02819
• Device Sequence Number: 15468401
• Product Code: HWC
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown