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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
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
It was reported that during a distal radius fracture surgery the drp plate ar-8916vsl-03s (lot: 15167246) failed in the top-left locking hole.It was not possible to insert the locking screw, as it just didn¿t hold the screw.The surgeon switched to another plate ar-8916vsl-03s (lot: 15167246) and the screw got stuck in the locking hole on the second plate.The screw got almost welded into the plate, and the surgeon couldn`t remove it, and accepted the position even though not ideal.The second plate remained in the patient, in an acceptable way.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the second plate with the same part- and lot no.As the first one.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 user error of the device due to misaligned insertion.

• 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: 21678766
• Report Number: 1220246-2025-01133
• Device Sequence Number: 7599863
• Product Code: HRS
• UDI-Device Identifier: 00888867211735
• UDI-Public: (01)00888867211735(11)231114(17)281031(10)15167246
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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 LT 3H, STRL
• Device Catalogue Number: AR-8916VSL-03S
• Device Lot Number: 15167246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown