MAUDE Adverse Event Report: ARTHREX, INC. 5.5X32MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X32MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/16/2025, it was reported by a sales representative via email that (qty.2) of an ar-9563-32 peripheral screw failed to thread into the baseplate.Two different locking screws from separate lots were attempted, but neither fit.As a result, the surgeon opted for a non-locking screw to complete the procedure.No components broke in the patient.This was discovered during a reverse shoulder arthroplasty procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 a most likely cause.Per surgical technique univer revers modular glenoid system - screw angulation - note: the screw angulation of nonlocking (variable-angle) and locking screws changes slightly based on the chosen baseplate.For specific angles, reference the chart.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or excessive mechanical forces during use.

• Brand Name: 5.5X32MM PERIPHERAL SCREW, LOCKING
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 22009328
• Report Number: 1220246-2025-02027
• Device Sequence Number: 5343072
• Product Code: PHX
• UDI-Device Identifier: 00888867296886
• UDI-Public: 00888867296886
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 5.5X32MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-32
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown