MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD RT 5H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD RT 5H
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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 (b)(6) 2025, it was reported by a sales representative via email that two 2.4 mm val screws went through an ar-8916vsr-05 volar distal radius plate during insertion.The entire construct had to be removed in order to change plates.The plates were changed to a wide plate and the surgeon re-drilled and re-sized the screws.This was discovered during a distal radius fracture procedure on (b)(6) 2025.Additional information has been requested on 4/8/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 4/15/2025: nothing broke inside the patient.The case was successfully completed with a new plate and screws.However, the procedure was delayed by approximately forty-five minutes, requiring the administration of additional anesthesia.Additional information was requested on 5/6/2025.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation was confirmed.The returned screws passed through the hole when excessive force was applied.One unpackaged ar-8916vsr-05 volar distal rad plt ti std rt 5h batch 132169 was received for evaluation.Visual inspection revealed signs of cross-threading in the upper holes.The thread in hole "a" was severely damaged.Additional observations included thread damage, scratches, and dents around the device.Additonal inspection included the measurement of the screws critical dimension by drawing c6245 at revision 11.It was found that all the screws critical dimension are within drawing specification.Functional testing was conducted by attaching the returned low profile va locking screw to the holes.The testing also involved the use of a torque driver (ar-8950rh handle and ar-8916-27 driver).During the procedure, a distinct sound was noted when the screwdriver reached its torque limit, indicating proper engagement.The device was then positioned centrally, and additional force was applied.Under this increased force, it was observed that the screw passed through the hole.The most likely cause of the reported failure is user error, specifically the application of excessive force and/or failure to set the torque driver to the correct setting.
Event or Problem Description
Additional information received on 6/3/2025: a total of five products were received.An ar-8916vsr-05 volar distal radius plate, an ar-8724v-20 low profile va locking screw, an ar-8724v-22 low profile va locking screw, an ar-8724v-28 low profile va locking screw, and an ar-8935-18 low profile non-locking screw.

• Brand Name: VOLAR DISTAL RAD PLT TI STD RT 5H
• 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: 21855556
• Report Number: 1220246-2025-01514
• Device Sequence Number: 11942448
• Product Code: HRS
• UDI-Device Identifier: 00888867131156
• UDI-Public: (01)00888867131156(11)240123(10)15132169
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2025

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: VOLAR DISTAL RAD PLT TI STD RT 5H
• Device Catalogue Number: AR-8916VSR-05
• Device Lot Number: 15132169
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 06/03/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/07/2025; 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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