MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK COMPRESSION SCREW, SS, 2.7X14MM; BONE FIXATION SCREW/PLATE

Model Number	KREULOCK COMPRESSION SCREW, SS, 2.7X14MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided¿which may include the returned device (if available), photographs, videos, event description, and any additional field input¿arthrex has determined the most likely cause of the reported event.The most likely cause is patient-specific hypersensitivity or allergy.Per dfu-0335-eo, revision 2, contraindications: foreign body sensitivity is a consideration, and where material sensitivity is suspected, appropriate testing should be performed, and sensitivity ruled out prior to implantation.D.Adverse effects: the possibility of foreign body reactions.Warnings note that stainless steel screws contain nickel, and that patients with sensitivity to this material may experience a reaction, further advising that patients should be counseled on material composition and sensitivity ruled out prior to implantation if suspected.
Event or Problem Description
On 02-jan-2025, a patient called in reporting that after undergoing an ankle procedure in (b)(6) 2025, she had experienced a reaction, along with experiencing her skin changing, and pain near her ankle.Additional information was provided on 24-mar-2026 where the patient reported that she underwent a left ankle procedure for a displaced bimalleolar fracture of the lower leg on (b)(6) 2025 where an ar-8943dl-04 locking distal fibula plate, ar-8827-18 low profile screw¿, 2.7 x 18 mm, (3) ar-8827cl-12 kreulock¿ compression screw, ss, 2.7 mm x 12 mm, ar-8827cl-14 kreulock¿ compression screw, ss, 2.7 mm x 14 mm, (2) ar-8827cl-16 kreulock¿ compression screw, ss, 2.7 mm x 16 mm, (3) ar-8835cl-12 kreulock¿ compression screw, ss, 3.5 mm x 12 mm, ar-8835-14 low profile screw¿, ss, 3.5 x 14 mm, cortical, and an ar-8925ss syndesmosis tightrope® xp, stainless steel were implanted.The patient began to experience the following symptoms in (b)(6) 2025; runny nose, diarrhea, blurred vision, sensitivity to the ankle, bottom of the toes ache, changes in skin, blood pressure going up and down, back of heels ache, itchy ankle; that is being treated with a cream, sharp pain in the ankle, right ear blocked, mucus in the throat, achy knees, can see more knots in the veins in the legs, and hands, teeth beginning to turn brown, the feeling of a tight rubber band around her ankle.It was noted that the patient is allergic to palladium chloride, and the material composition has been requested.

• Brand Name: KREULOCK COMPRESSION SCREW, SS, 2.7X14MM
• 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: 24957084
• Report Number: 1220246-2026-02358
• Device Sequence Number: 15959960
• Product Code: HRS
• UDI-Device Identifier: 00888867324145
• UDI-Public: 00888867324145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KREULOCK COMPRESSION SCREW, SS, 2.7X14MM
• Device Catalogue Number: AR-8827CL-14
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown