MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Arthrofibrosis (4885)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05-jan-2026, it was reported by the patient via email that the patient underwent patellar tendon reconstruction in (b)(6) 2025, during which arthrex biceps button fixation devices were utilized by the operating surgeon.Following the procedure, the patient experienced substantial postoperative complications that significantly impacted recovery and functional outcome.The patient noted that these complications have been severe and persistent.No additional details were provided.Additional information was received on 16-jan-2026: the patient underwent right patellar tendon reconstruction on (b)(6) 2024 following a patellar tendon rupture on (b)(6) 2024.The procedure utilized two ar-2260bc biocomposite distal biceps implant systems and one ar-2323bct-2 biocomposite swivelock suture anchor.Approximately three weeks postoperatively, the patient reported early symptoms, noting that ¿something felt wrong,¿ though the operating surgeon initially advised this was within normal postoperative expectations.The patient subsequently developed severe knee stiffness, inability to bend the knee, and episodes of knee locking.These symptoms required a second surgery, after which the range of motion improved and the knee locking resolved.Despite improvement, the patient continues to experience persistent stiffness described as a ¿bungee cord pulling across the knee,¿ as well as swelling when not wearing a compression sleeve.The patient reports that the swelling and stiffness contribute to discomfort in the hip and ankle.The patient states they do not experience pain in a neurotypical manner, and stiffness remains the primary ongoing concern.Medical management has included physical therapy, acupuncture, and imaging.The current treating physician evaluated the patient on (b)(6) 2026 and diagnosed multiple severe arthrofibrosis.The surgeon advised that the patient¿s current functional status is likely their new baseline, with potential for gradual improvement over time.Revision surgery is not indicated at this time.Additional information was received on 20-jan-2025: the patient previously underwent patellar tendon surgery and subsequently experienced complications, including significant difficulty with knee flexion, episodes of knee locking, and severe arthrofibrosis.On (b)(6) 2025, the patient sustained a fall attributed to knee locking.Mri imaging later demonstrated a high-grade acl tear.On (b)(6) 2025, the patient¿s current physician performed acl reconstruction along with medial and lateral meniscectomies.Following this procedure, the patient has regained full knee range of motion and no longer experiences locking; however, residual symptoms from the initial patellar tendon surgery persist, though they are gradually improving.At a follow-up visit on (b)(6) 2026, the patient¿s current physician indicated that a patellar tendon revision is not anticipated to be necessary.The surgeon advised that the remaining symptoms are likely baseline postoperative findings and are expected to continue improving with time and ongoing care.
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 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.The most likely cause is patient-specific; no evidence of device malfunction or defect was identified.The patient¿s reported postoperative complications are consistent with severe arthrofibrosis, a known patient-specific complication following knee reconstruction procedures.Per dfu-0314-eo revision 3, c.Contraindications: 3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.4.Any active infection or blood supply limitations.5.Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.6.The use of this device may not be suitable for patients with insufficient or immature bone.The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 24129217
• Report Number: 1220246-2026-00255
• Device Sequence Number: 10400633
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: (01)00888867204645(11)240716(17)260630(10)15288350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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 Expiration Date: 06/30/2026
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 15288350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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