MAUDE Adverse Event Report: ARTHREX, INC. 4X36MM BEVELED FT SCREW; BONE FIXATION SCREW/PLATE

Model Number	4X36MM BEVELED FT SCREW
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 5/30/2024, it was reported by a sales representative via email that a beveled screw had shards of metal coming out of the screw.This was discovered during a hardware removal procedure.It was reported that the patient's bunion cut was healed but was experiencing an inflammatory response.No additional information was provided.Additional information requested.Additional information received on 6/26/2024: the original procedure was an mis bunion performed on (b)(6) 2023.An ar-8735bv-32 beveled ft screw 3.5 mm x 32 mm and an ar-8740bv-36 beveled ft screw 4.0 mm x 36 mm were implanted.The revision surgery occurred on (b)(6) 2024, and both screws were removed.After the removal of the screw, the case was completed without new hardware.The revision surgery was performed due to heat and irritation on the medial side of the foot.The foreign body could be seen on initial x-ray.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on visual evaluation and 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 user error of the device due to excessive force being used during insertion of the screw.

• Brand Name: 4X36MM 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: 19743971
• Report Number: 1220246-2024-06754
• Device Sequence Number: 12681086
• Product Code: HWC
• UDI-Device Identifier: 00888867361393
• UDI-Public: 00888867361393
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4X36MM BEVELED FT SCREW
• Device Catalogue Number: AR-8740BV-36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown