MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 40MM; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,3.5 MINI, 40MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
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.One unpackaged ar-8730-40h serial/batch number l1812100 was received for investigation.Visual evaluation found that the mini compression ft¿, titanium, 3.5 mm x 40 mm, is missing the hexalobe shape specified on the drawing (b)(4).This is a known manufacturing issue.Refer to (b)(4).Based off the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue.
Event or Problem Description
On 1/27/2023, it was reported by a distributor via sems that an ar-8730-40h mini compression ft screw did not have the inner threads for the screwdriver to hold on to.This was discovered during a latarjet left shoulder procedure on (b)(6) 2023.Case was completed using another ar-8730-40h mini compression ft screw.

• Brand Name: COMPR FT SCRW,3.5 MINI, 40MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19560588
• Report Number: 1220246-2024-05982
• Device Sequence Number: 6806526
• Product Code: HRS
• UDI-Device Identifier: 00888867303324
• UDI-Public: 00888867303324
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: COMPR FT SCRW,3.5 MINI, 40MM
• Device Catalogue Number: AR-8730-40H
• Device Lot Number: 14923525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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