MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,36MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,2.5 MICRO,36MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
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 06/02/2025, a sales representative reported via email an issue involving an ar-8725-36h micro compression ft during a dip fusion procedure on (b)(6) 2025.While inserting the 2.5 headless compression screw, the tip of the cannulated driver broke within the head of the screw, and the distal tip of the screw fractured during insertion.Additional information requested on 6/18/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 06/24/2025: fragments from the tip of the ar-8725-36h micro compression ft screw were retrieved from the patient using suction.The driver used with the screw for insertion during the event was ar-8737-37 driver shaft.The procedure was completed by implanting a shorter screw, the ar-8725-34h micro compression ft, and utilizing an ar-8737-37 driver shaft.The case experienced a delay of approximately 30 minutes to one hour.No additional anesthesia was administered to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.- one unpackaged ar-8725-36h, micro compression ft¿, titanium, 2.5 mm x 36 mm, batch 129038, was received for investigation.- upon visual inspection, it was noted that the distal and proximal ends of the screw were damaged/stripped and the tip of the screw was broken.No fragments were returned for investigation.- functional testing was not performed due to the damage to the device.- the most likely cause of the reported failure is user error, which can be attributed to over-torquing/over-engaging the driver within the screw.-refer to the investigation photos.-complaint allegation is confirmed.

• Brand Name: COMPR FT SCRW,2.5 MICRO,36MM 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: 22298366
• Report Number: 1220246-2025-02596
• Device Sequence Number: 12970981
• Product Code: HWC
• UDI-Device Identifier: 00888867303270
• UDI-Public: 00888867303270
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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,Followup
• Report Date (Section B): 09/25/2025

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,2.5 MICRO,36MM LGTH
• Device Catalogue Number: AR-8725-36H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 09/19/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/18/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown