MAUDE Adverse Event Report: ARTHREX, INC. 2.4X16MM VAL NEAR CORTEX SCREW, TI, STRL; BONE FIXATION PLATE

Model Number	2.4X16MM VAL NEAR CORTEX SCREW, TI, STRL
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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 (b)(6) 2025, an arthrex subsidiary employee reported via email that an ar-8916vnc-18s val near cortex screw (2.4 mm x 18 mm), ar-8916vnc-16s val near cortex screw (2.4 mm x 16 mm), ar-8916vnc-14s val near cortex screw (2.4 mm x 14 mm), and an ar-8916vnr-03s volar distal radius plate were implanted in the patient during surgery to repair a distal radius fracture on (b)(6) 2025.During postoperative follow-up, it was confirmed that three screws in the distal-most row had loosened.No further displacement was observed during follow-up, and the patient reportedly healed without incident.As part of the treatment plan after healing, the screws were removed on (b)(6) 2025 for a distal radius fracture repair procedure.The loose screws were identified as ar-8916vnc-18s val near cortex screw (2.4 mm x 18 mm), ar-8916vnc-16s val near cortex screw (2.4 mm x 16 mm), and ar-8916vnc-14s val near cortex screw (2.4 mm x 14 mm).The plate part number was ar-8916vnr-03s volar distal radius plate.The surgery was completed without issues using a product with the same part number.No specific details were provided regarding the bone preparation or bone quality.No significant delay or additional anesthesia was administered, and no adverse effects were noted during or after the surgery.Additional information has been requested on (b)(6) 2025.
Event or Problem Description
Additional information was received on 10/14/2025: the loosening was identified during a routine follow-up and was not associated with any patient symptoms such as pain or swelling.No intraoperative issues were reported during the original surgery on (b)(6) 2025.The specific date when the loosening was first detected is unknown.No additional interventions, such as medications or treatments, were required prior to the planned screw removal.The patient is currently in good health, and no further surgeries are planned in relation to this issue.The removal of the three screws and the plate was performed as part of a planned plate removal surgery, in accordance with the patient¿s recovery progress.Additional information was received on 11/04/2025: the part number ar-8916vnc-14s val near cortex screw (2.4 mm x 14 mm) was incorrect for this allegation.The correct part number is ar-8916vnc-18s val near cortex screw (2.4 mm x 18 mm).A total of two ar-8916vnc-18s val near cortex screws (2.4 mm x 18 mm) were involved.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Additional information: b1, d6a, d6b, g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-8916vnc-16s, which displays the explanted devices.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.Per directions for use (dfu) dfu-0125-eo arthrex low profile screws, revision 8, e.Warnings 6.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.

• Brand Name: 2.4X16MM VAL NEAR CORTEX SCREW, TI, STRL
• Common Device Name: BONE FIXATION 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: 23435425
• Report Number: 1220246-2025-04922
• Device Sequence Number: 11957866
• Product Code: HRS
• UDI-Device Identifier: 00888867242616
• UDI-Public: 00888867242616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.4X16MM VAL NEAR CORTEX SCREW, TI, STRL
• Device Catalogue Number: AR-8916VNC-16S
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 02/02/2026; 06/29/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/12/2025; 02/05/2026; 06/30/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown