MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW, CANN, BLUNT TIP, 4 X 38 MM; SMOOTH FIXATION PIN

Model Number	LO-PRO SCRW, CANN, BLUNT TIP, 4 X 38 MM
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient reported via email that they had undergone patella repair surgery on (b)(6) 2022, during which two ar-5051-38 low profile screws (cannulated, blunt tip, 4 x 38 mm) were implanted.The patient began experiencing a systemic reaction approximately nine months postoperatively, which has persisted to the present day.To support future healthcare and treatment decisions, the patient has requested the metallurgical composition of the implanted screws.Additional information has been requested on 08/28/2025: on (b)(6) 2022, the patient underwent an open reduction and internal fixation (orif) procedure to treat a transverse displaced fracture of the left patella.The injury occurred on (b)(6) 2022, when the patient fell while ascending carpeted stairs at an airport while carrying a backpack.Beneath the carpeting was a metal edge, which caused a direct impact to the left knee from an estimated height of 12¿14 inches, resulting in the fracture.During the procedure, two ar-5051-38 low profile screws were implanted.However, the lot numbers for these screws remain unknown, and it is currently unclear whether additional arthrex components were used.Approximately nine months post-surgery, in (b)(6) 2023, the patient began experiencing systemic dermatological symptoms.Initial signs included dark bruising on the shins, which progressed to red, itchy lesions with open wounds.Between (b)(6) 2024 and the present, symptoms extended to the palms, which became red, swollen, flaking, and covered in painful cuts.The left ankle also became swollen, with involvement of the achilles tendon, significantly affecting mobility.A preliminary diagnosis of psoriatic arthritis was ruled out in (b)(6) 2025 following sedimentation rate blood testing.The condition continued to evolve, with painful fissures developing on the soles of both feet, primarily affecting the heels and the central part of the foot area.Over the past year, the patient has attended eight dermatology and nine allergy consultations.One specialist, prompted by the presence of surgical screws, conducted a metal sensitivity panel involving 110 samples.The patient tested positive for titanium (highest reactivity), gold, and iridium.Treatment efforts included eight physical therapy sessions in february and (b)(6) 2025, which improved the achilles.Topical management with chlobestrol provided partial symptom control; however, discontinuation led to rapid recurrence of flaking, thickening, and bleeding of the affected areas.The patient has relied heavily on bandages over the past 16 months.Meloxicam was prescribed to manage swelling and pain in the left ankle, yielding moderate relief.The surgical site itself healed without complication, and no issues were reported during or immediately following the procedure.No additional surgeries have been performed since (b)(6) 2022, though further surgical intervention is currently under consideration due to the ongoing systemic reaction.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, g3, h3, h6.The complaint allegation is not able to be confirmed based on the provided images.Visual evaluation of the provided x-ray images noted pre & post patella repair with internal fixation and an image of a screw.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to a patient-specific event.

• Brand Name: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 38 MM
• Common Device Name: SMOOTH FIXATION PIN
• 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: 23020538
• Report Number: 1220246-2025-03813
• Device Sequence Number: 18535041
• Product Code: HTY
• UDI-Device Identifier: 00888867217614
• UDI-Public: 00888867217614
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 38 MM
• Device Catalogue Number: AR-5051-38
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown