MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK COMPRESSION SCREW, SS, 3.5X10MM; BONE FIXATION PLATE

Model Number	KREULOCK COMPRESSION SCREW, SS, 3.5X10MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a patient reported via phone to have experienced a trimalleolar ankle fracture of the right leg.During the initial consultation on (b)(6) 2022, the patient requested titanium implants due to a nickel allergy.On (b)(6) 2022, the patient underwent surgery and had an ar-8835-12 low profile screw, two ar-8835-14 low profile screws, an ar-8835-16 low profile screw, an ar-8835cl-10 kreulock compression screw, two ar-8835cl-16 kreulock compression screws, two ar-8840c-45 low profile screws, and an ar-8943t-08 locking third tubular plate implanted, all of which are composed of stainless steel.There were no reports of any issues during the surgery.Three months later, the patient started to experience healing problems, swelling, a change in the knee color, and the ankle becoming hot to the touch.The patient was diagnosed with complex regional pain syndrome stage one.The patient underwent revision surgery on (b)(6) 2022 by the same surgeon to have all the previously implanted screws and plate removed; no new arthrex products were implanted.After the surgery, the patient was given a boot.Due to the allergic reaction to the implants, the patient developed decreased mobility and needed physical therapy.A year or so later, the patient consulted a different surgeon who suggested a third surgery to clean up scar tissue.Before surgery on (b)(6) 2024, the patient received ketamine infusions to get complex regional pain syndrome under control.After the surgery, the patient was informed that a fourth cartilage break was missed in the initial surgery.The third surgery cleared up the scars and lesions, improved the patient's mobility, and returned normal leg color.The patient is working on the remission of complex regional pain syndrome.
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 a patient-specific event, such as foreign body sensitivity.The complaint allegation was not confirmed.No evidence of the failure was received.

• Brand Name: KREULOCK COMPRESSION SCREW, SS, 3.5X10MM
• 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: 21322653
• Report Number: 1220246-2025-00258
• Device Sequence Number: 7918547
• Product Code: HRS
• UDI-Device Identifier: 00888867323032
• UDI-Public: (01)00888867323032(11)200915(10)11705438
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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, 3.5X10MM
• Device Catalogue Number: AR-8835CL-10
• Device Lot Number: 11705438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown