MAUDE Adverse Event Report: ARTHREX, INC. 3.5X38MM BEVELED FT SCREW; BONE FIXATION SCREW/PLATE

Model Number	3.5X38MM BEVELED FT SCREW
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
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 10/29/2024, it was reported by a facility representative that a patient who was part of the clinical research study returned for a three month's visit, in which it was found that out of the three screws implanted, two were protruding into the mcp joint space.It was determined that removing the screw was the next step.No further information was provided.Additional information received on 11/18/2024: the patient underwent initial right-hand surgery on (b)(6)2024 due to a motor vehicle accident.During the procedure, an ar-8740bv-44 beveled ft screw, an ar-8740bv-50 beveled ft screw, an ar-8735bv-38 beveled ft screw, and an ar-8725-38h micro compression ft screw were implanted.The patient did not suffer any fall, injury, or trauma to the hand that could have caused the screws to protrude.As of (b)(6)2024, the screws remain implanted, and a revision surgery has not occurred.At this time, it is unknown which screws are protruding.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received on 12/16/2024: the two protruding screws are in the third and fourth metacarpals.A revision surgery has been scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: 3.5X38MM BEVELED FT SCREW
• 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: 20835329
• Report Number: 1220246-2024-08687
• Device Sequence Number: 3864763
• Product Code: HWC
• UDI-Device Identifier: 00888867360822
• UDI-Public: 00888867360822
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K210994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2025

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: 3.5X38MM BEVELED FT SCREW
• Device Catalogue Number: AR-8735BV-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 06/12/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/13/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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