MAUDE Adverse Event Report: ARTHREX, INC. VAL KREULOCK SCREW, TI, 3.0X20; BONE FIXATION PLATE

Model Number	VAL KREULOCK SCREW, TI, 3.0X20
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 16th june 2025, it was reported by an arthrex employee via email that for an ar-9944s-0r, maxforce¿ mtp compression plate, std, 0° valgus, 0° dorsiflex, right and an ar-8933vcl-20, kreulock¿ compression screw, ti, 3 mm x 20 mm, during the insertion of the 3mm kruelock screw, it fell through the plate and was not engaging the locking thread.The screw was checked to confirm 3mm fitting on t10 screwdriver.2mm drill was used through fixed locking tower.The surgeon was unable to remove screw and it remains in patient.This was detected during use in an unspecified procedure on 1(b)(6) 2025.On (b)(6) 2025: the complaint initiator replied that this was detected during use in a mtpj fusion procedure on (b)(6) 2025.The procedure was completed successfully.On (b)(6) 2025: the complaint initiator replied with the batch numbers however, for ar-8933vcl-20, the complaint initiator is unsure which was the batch number of the defective screw as 2 ar-8933vcl-20 were used but the complaint initiator could not identify which one of the two screws was related to the defect complaint.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted a screw had gone through the plate.Refer to attachments.Based on the information provided, 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 applying excessive mechanical forces during screw insertion and/or over-torquing the screw during insertion.The dfu for this device, dfu-0336-eo revision 1, gives the following precaution: 5.Screws should be inserted by hand and not with powered equipment.

• Brand Name: VAL KREULOCK SCREW, TI, 3.0X20
• 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: 22440605
• Report Number: 1220246-2025-02776
• Device Sequence Number: 14243924
• Product Code: HRS
• UDI-Device Identifier: 00888867324213
• UDI-Public: (01)00888867324213(11)231016(10)15154896
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K242554
• 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): 10/14/2025

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: VAL KREULOCK SCREW, TI, 3.0X20
• Device Catalogue Number: AR-8933VCL-20
• Device Lot Number: 15154896
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown