MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,44MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,4.0 STD,44MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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 (b)(6) 2024, it was reported by an arthrex subsidiary employee via email that an ar-8740-44h standard compression ft screw broke when tightened.The screw broke about 4 mm before the final placement.It was removed, and a new ar-8740-44h standard compression ft screw was implanted.There were no fragments left in the patient.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8740-44h, batch 10271369, was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the device was broken on the proximal end.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the screw during use.

• Brand Name: COMPR FT SCRW,4.0 STD,44MM LGTH
• 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: 20524726
• Report Number: 1220246-2024-08251
• Device Sequence Number: 8119525
• Product Code: HWC
• UDI-Device Identifier: 00888867127845
• UDI-Public: (01)00888867127845(11)190121(10)10271369
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: COMPR FT SCRW,4.0 STD,44MM LGTH
• Device Catalogue Number: AR-8740-44H
• Device Lot Number: 10271369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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