MAUDE Adverse Event Report: ARTHREX, INC. 5.5X16MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X16MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
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 19-dec-2025, a sales representative reported via phone that an ar-9563-16 peripheral locking screw did not lock into an ar-9580-2410s 24mm base plate during a reverse shoulder arthroplasty procedure on (b)(6) 2025.The issue was resolved by using two replacement ar-9563-20 peripheral locking screws (5.5 x 20 mm) to complete the case.There was no delay, no additional anesthesia, and no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed.The returned screw measurements and functional test confirmed that it is a good device.One unpackaged ar-9563-16 peripheral locking screw batch 15385060, laser marked on the screw 15320825, was received for evaluation.Visual inspection noted damage to the threads, including nicks and loss of anodized color on the edges, most likely caused by friction during attempts to set the screw on the base plate.A functional test was performed using a known good device.The received ar 9563-16 locked into the holes without issue.The device was measured according to drawing c14928, revision 4, and component c14928-01, revision 3.Overall length.0.630 ± 0.012 inches result: 0.628 inches.Major diameter of the threads: ø 0.217 + 0.000/- 0.005 inches, result: 0.215 inches.Minor diameter of the threads: ø 0.118 +.000/-0.005 inches, result: 0.116 inches.Major diameter of the head threads: ø 0.266 ± 0.002 inches, result: 0.266 inches.Minor diameter of the threads: ø 0.232 + 0.002/-0.001 inches, result: 0.233 inches.The most likely cause of the reported failure is a use error, including misalignment of the screw insertion and/or improper surgical technique associated with the device.

• Brand Name: 5.5X16MM 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: 24035625
• Report Number: 1220246-2026-00130
• Device Sequence Number: 10472802
• Product Code: PHX
• UDI-Device Identifier: 00888867296800
• UDI-Public: (01)00888867296800(11)250206(17)300131(10)15385060
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/28/2026

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: 5.5X16MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-16
• Device Lot Number: 15385060
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown