MAUDE Adverse Event Report: ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X20MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/29/2025, it was reported by a sales representative via (b)(4) that an ar-9563-20 peripherial screw would not fully seat.Surgeon used appropriate locking guide and drill for using the screw but couldn¿t get the screw to fully seat.He backed the screw out, re drilled, and then attempted to put the same screw in with the same result.He then backed it out and noticed that the screw appeared to be cross threaded and/or defective.We put in a shorter 16 mm screw in its place, and it sat flush.No harm was done to patient and the alternative solution was shorter screw.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9563-20 batch 15331276 was received for evaluation.Upon visual inspection, the threads at the head showed signs of cross-threading.Bending of the threads was also observed, likely caused by the force applied when setting the screw onto the plate.Due to the damage to the screw, functional testing cannot be performed.The most likely cause of the reported failure is user error, including improper bone preparation and failure to achieve the appropriate insertion angle.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9563-20 batch 15331276 was received for evaluation.Upon visual inspection, the threads at the head showed signs of cross-threading.Bending of the threads was also observed, likely caused by the force applied when setting the screw onto the plate.Due to the damage to the screw, functional testing cannot be performed.The most likely cause of the reported failure is user error, including improper bone preparation and failure to achieve the appropriate insertion angle.The complaint allegation was confirmed.Refer to the investigation pictures.

• Brand Name: 5.5X20MM 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: 22296688
• Report Number: 1220246-2025-02579
• Device Sequence Number: 8875467
• Product Code: PHX
• UDI-Device Identifier: 00888867296824
• UDI-Public: 00888867296824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 10/13/2025

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: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-20
• Device Lot Number: 15366476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 10/07/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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