MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 16MM VAL SCREW, TI; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 16MM VAL SCREW, TI
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/15/2025, a sales representative reported via email that one ar-8933v-14 low profile va locking screw, one ar-8933v-16 low profile va locking screw, and two ar-8933v-18 low profile va locking screws were unsuccessfully threaded through a locking distal fibular plate, despite appropriate drilling techniques.As a result, all four screws were discarded, and the plate hole remained unfilled.This was discovered during an orif ankle procedure on (b)(6) 2025.Additional information was received on 07/21/2025: on (b)(6) 2025, during an orif ankle procedure, an ar-9943bl-05 locking distal fibula plate was implanted and remains in the patient.There was no report of implant breakage during the incident.The procedure was delayed by approximately 10 minutes due to difficulty engaging the screws, which required redrilling and reinsertion.Additional anesthesia was administered to accommodate the extended operative time.An ar-8933gv drill guide and an ar-8943-16 2.0 mm drill bit were used to prepare the bone socket for implant placement.Bone quality was assessed as adequate, and no photographs were taken to document the issue.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 3.0 X 16MM VAL SCREW, TI
• 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: 22698654
• Report Number: 1220246-2025-03213
• Device Sequence Number: 12998090
• Product Code: HWC
• UDI-Device Identifier: 00888867050235
• UDI-Public: (01)00888867050235(11)190109(10)10268846
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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): 11/06/2025

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: 3.0 X 16MM VAL SCREW, TI
• Device Catalogue Number: AR-8933V-16
• Device Lot Number: 10268846
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown