MAUDE Adverse Event Report: ARTHREX, INC. 5.5X28MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X28MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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 11/05/2024, it was reported by a sales representative via sems-06704164 that an ar-9625 3.0 mm hex driver tip broke off when tightening the locking screw into the mgs baseplate.It was retrieved from the screw head.The surgeon was not using the torque indicator as per their preference when the driver broke, a replacement screwdriver was attached to the torque indicator, and the screw was confirmed to be torqued down.No delay in the case and the case was completed successfully.This was discovered during an rtsa procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 11/08/2024: the torqued down screw was part number ar-9563-28 lot 15202638.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: 5.5X28MM 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: 20843726
• Report Number: 1220246-2024-08693
• Device Sequence Number: 20843114
• Product Code: PHX
• UDI-Device Identifier: 00888867296862
• UDI-Public: 00888867296862
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/08/2025

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: 5.5X28MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-28
• Device Lot Number: 15202638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown