MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DIST RAD PLT TI NARROW RT 3H, STRL; BONE FIXATION PLATE

Model Number	VOLAR DIST RAD PLT TI NARROW RT 3H, 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.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 Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
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: b1, d6a, d6b, g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of an ar-8916vnr-03s, batch 15201494, that 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-0192-eo arthrex plates, 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is not confirmed.Evaluation of the customer-provided x-rays suggests that one of the distal screws appears proud, which may indicate loosening or backing out.It may also indicate that the screw was not seated flush against the plate during the initial surgery.One unpackaged ar-8916vnr-03s volar distal radius plate, ti, narrow, right, 3h, sterile, batch 15201494, lasered batch on the plate 15169241 was received for evaluation.Visual inspection identified damage to the threads of holes c, b, and a and, to the outer diameter of hole f.Multiple scratches and deep marks were also observed on the plate.Functional testing was conducted using the returned screws.The screws were successfully engaged in holes c, b, and a and were observed to sit flush within each hole.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.Additional evaluation included dimensional inspection of critical measurements for holes a¿f, performed in accordance with drawing c4105, revision 12, for component c4105-15, revision 3 (volar distal radius plate, narrow, right/left).Dimensional inspection: pin gauge ø 0.158 ±.005 inches pin gauge 6x ø 0.129 ±.001 inches - minor diameter.Pin gauge 6x ø 0.150 + 0.004/-0.000 inches.Major thread diameter and unthreaded diameter.The results indicate that the diameter of the holes is within the drawing specifications.Based on the information provided and device evaluation, the most likely cause of the reported failure is improper torque application.Use of a torque-limiting driver is recommended to ensure proper torque and prevent over- or under-tightening of the screws.Refer to directions for use dfu-0192-eo, revision 6 ¿ arthrex plates, sections g.(precautions) for important information.Please refer to the arthrex website for the correct insertion method as outlined in the surgical technique guide and accompanying online videos.

• Brand Name: VOLAR DIST RAD PLT TI NARROW RT 3H, 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 23435424
• Report Number: 1220246-2025-04924
• Device Sequence Number: 4783161
• Product Code: HRS
• 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: VOLAR DIST RAD PLT TI NARROW RT 3H, STRL
• Device Catalogue Number: AR-8916VNR-03S
• Device Lot Number: 15201494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 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
• Date Device Manufactured: 02/01/2024
• 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