MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	25MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion.
Event or Problem Description
On 10/21/2022, it was reported by a sales representative via phone that an ar-9561-25s 25mm central screw, modular had an issue.During a total reverse shoulder procedure on (b)(6) 2022, when the surgeon was trying to insert the screw into the baseplate on the back table, it would not sit flush.There was no damage visible to the eye, the screw did not look damaged or bent in any way.As the complaint device would not sit flush, it was not used in the surgery.They did not have another screw at hand, so an ar-9561-25p univers revers modular glenoid system, central post, modular 25 mm with lot number 14968556 was used to complete the case successfully with no impact to the patient, that device did fit well.The complaint device was discarded, and no pictures were taken.

• Brand Name: 25MM CENTRAL SCREW, MODULAR
• 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: 19154507
• Report Number: 1220246-2024-02213
• Device Sequence Number: 7834375
• Product Code: PHX
• UDI-Device Identifier: 00888867296565
• UDI-Public: 00888867296565
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: 25MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-25S
• Device Lot Number: 14971780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown