MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD LT 3H, STRL; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD LT 3H, STRL
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2025
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, it was reported by an arthrex employee via email that when inserting an ar-8724v-20s (low profile va locking screw, 2.4 x 20 mm, sterile), it passed through the plate (ar-8916vsl-03s volar distal radius plate, ti, standard, left, 3 hole) without being locked and was left inside the patient's bone.This occurred during a distal radius fracture case on (b)(6) 2025.The method of inserting the screw was firstly to affix the ar-8916-02 (aiming guide vdr plate standard l) to the plate before inserting the screw.The screw is not swung with the variable screw, and the angle is fixed.The driver used was ar-8916tl-011, and the screw was not inserted with excessive force.The other screws were locked without any problems.At the doctor's discretion, the plate and buried ar-8724v-20s screw were left in the patient's body and the surgery was completed.Only the driver and aiming guide will be returned to arthrex.The procedure was not considered to be completed successfully as the ar-8724v-20s screw in question was in an incomplete fixed state while there were no problems with the screw fixation in other areas.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded that the most likely cause of the reported failure was user error.This includes the application of excessive torque force to the ratchet.The complaint allegation was confirmed based on the customer's attached pictures, which showed that the screw had passed through the plate.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 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 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22026339
• Report Number: 1220246-2025-02052
• Device Sequence Number: 7220707
• Product Code: HRS
• UDI-Device Identifier: 00888867211735
• UDI-Public: (01)00888867211735(11)240710(17)290630(10)15285787
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: VOLAR DISTAL RAD PLT TI STD LT 3H, STRL
• Device Catalogue Number: AR-8916VSL-03S
• Device Lot Number: 15285787
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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