MAUDE Adverse Event Report: ARTHREX, INC. 30MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	30MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
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.Complaint is confirmed.Visual evaluation, the edges of the hex screw and base of the central screw had damage.Functional testing identified that the returned device did not work as required.The probable cause of this condition of damage can be that the hex tip must be aligned between the components in order for the taper to engage and rotate the components until the hex features align, resulting in a tactile coupling and were not engaged properly.The most likely cause is attributed to misuse due to user error.
Event or Problem Description
It was reported that during an univers revers mgs surgery screw which is pressed into the plate did not hold.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 30MM 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: 19055896
• Report Number: 1220246-2024-01851
• Device Sequence Number: 8187756
• Product Code: PHX
• UDI-Device Identifier: 00888867296572
• UDI-Public: 00888867296572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 30MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-30S
• Device Lot Number: 14975759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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