MAUDE Adverse Event Report: ARTHREX, INC. INTERNALBRACE LIGAMENT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTERNALBRACE LIGAMENT
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2021
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, it was reported by a patient¿s legal representative via mail that the patient underwent a modified brostrom lateral ankle stabilization surgery of the left foot on (b)(6) 2019.During the procedure, two ar-1688-cp internalbrace ligament augmentation repair implant systems were used.For over a year following the surgery, the patient continued to report ongoing pain in the left foot during post-operative visits.On (b)(6) 2020, x-rays were taken, and it was reported to the patient that the hardware was intact, in proper position, and well seated.Despite this, the patient continued to report pain during various follow-up visits.The operating surgeon advised continued patience with conservative measures and treatment.On (b)(6) 2020, the patient sought another surgical opinion.A recent mri was reviewed, revealing a defect in the subtalar joint, and the patient was informed that surgery might be required to address the defect.Following nearly two years of continued pain and no meaningful improvement, and after consulting multiple surgeons, the patient was informed on (b)(6) 2021 that the lateral ligament repair anchor had penetrated the subtalar joint and was the source of the ongoing symptoms.On (b)(6) 2021, the patient underwent revision surgery.It was confirmed that the anchor implanted during the original procedure had been improperly placed within the subtalar joint space.The anchor was removed, and the revision surgeon elected to fuse the subtalar joint.It is currently unknown what devices were used during the revision surgery.Updated information received: arthrex sales records confirm the products used during the (b)(6) 2019 surgery were one ar-1688-cp internalbrace ligament augmentation repair implant system and one ar-8936bc-cp brostrom repair implant system.The patient¿s record identifies the utilization of two ar-1688-cp products, but further investigation indicates the utilization of one ar-1688-cp and one ar-8936bc-cp.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 a most likely cause.Per dfu-0087-eo - g precautions -.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.3.Make sure to use the recommended drill bit or punch to create the bone socket.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to a patient-specific event, and a use error, two related failures, as the anchor implanted during the original procedure was improperly positioned within the subtalar joint space, necessitating a revision surgery to alleviate patient discomfort.

• Brand Name: INTERNALBRACE LIGAMENT
• 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: 23006337
• Report Number: 1220246-2025-03789
• Device Sequence Number: 10502341
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: (01)00888867096080(11)190306(17)210228(10)10284270
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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 Expiration Date: 02/28/2021
• Device Model Number: INTERNALBRACE LIGAMENT
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 10284270
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2019
• 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