MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 18MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.5MMX 18MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
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 3/31/2025, 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 4/15/2025, 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 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.It was concluded that there is no allegation against part ar-8935-18.No problem found.One unpackaged ar-8935-18 batch unk was received for evaluation.Visual inspection revealed damage to the hexalobe hole.No damage was observed on the threaded body of the screw.Functional testing was not performed, as the device is directly screwed into the bone.It was concluded that there is no allegation against part ar-8935-18.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 18MM
• Common Device Name: BONE FIXATION SCREW/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: 22318373
• Report Number: 1220246-2025-02643
• Device Sequence Number: 12998992
• Product Code: HWC
• UDI-Device Identifier: 00888867050440
• UDI-Public: 00888867050440
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• 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
• 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: LO-PRO SCRW,TI,3.5MMX 18MM
• Device Catalogue Number: AR-8935-18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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