MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT, NUT

Model Number	IMPL SYS,CMC MINI T-ROPE,1.1 MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Skin Discoloration (2074); Sleep Dysfunction (2517); Limb Pain (4836); Complex regional pain syndrome (4899)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient reported via email that they had undergone a button suture procedure on their thumb approximately three months prior.Since the procedure, the patient has been experiencing excruciating pain, with nerve-like sensations radiating through various areas of the hand and wrist.The patient cannot type or lift objects, such as a soda bottle, and has now developed muscle atrophy in the affected region.No further details were provided.Additional information was received on 07/14/2025: on (b)(6) 2025, the patient underwent a left carpometacarpal interpositional arthroplasty and left intermetacarpal ligament reconstruction using a tissue graft to address basal joint pain.Arthrex products implanted during the procedure included the ar-8990st fibertak dx suture anchor, the ar-8988-cp fiberlock suspension implant kit, and the ar-8919ds cmc mini tightrope implant system.Prior to surgery, the patient received multiple injections over a 14-month period and underwent both mri and x-ray imaging.No additional surgical interventions have been performed since the initial procedure, and it remains uncertain whether further surgery will be scheduled.Additional information was received on 07/17/2025: the patient reports persistent wrist pain approximately 14 weeks following the procedure.Symptoms include a dull, electrical sensation and episodes of intense, sharp, and prolonged pain.These symptoms interfere with sleep, even with the use of a brace.Additionally, the patient experiences grinding and clicking sounds at the thumb base joint during movement.An mri of the wrist has been scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, d6a, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 08/05/2025: the patient is approximately four months post-operative and continues to experience persistent pain at the base of the thumb.The thumb frequently creaks and cracks with movement, often causing nighttime pain that disrupts sleep.The patient has also noted occasional skin discoloration, appearing black and blue.Physical therapy has proven ineffective and irritates the wrist.Despite the surgeon¿s assessment that everything appears normal, the patient reports that symptoms are now worse than prior to surgery.
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 descriptions, and any additional field information, arthrex was able to determine the most likely cause.Based on the documented event information, the reported event was most likely the result of one or a combination of the following factors: a patient-specific condition and/or failure to perform an appropriate sensitivity test prior to implantation.Directions for use.Dfu-0054-eor5_fmt_en.Bio-fastak, fastak¿, suturetak® and fibertak® suture anchors.C.Contraindications.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.4.Foreign body reactions.See adverse effects, allergic-type reactions.D.Adverse effects.2.Foreign body reactions.3.Allergic-type reactions to pla (poly lactic acid) materials (plla (poly-l-lactic acid), pldla (poly-l-d-lactic acid)) have been reported.These reactions have sometimes necessitated the removal of the implant.Patient sensitivity to device materials must be considered prior to implantation.Directions for use dfu-0147-eo tightrope® devices c.Contraindications.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.4.Foreign body reactions.See adverse effects, allergic-type reactions.D.Adverse effects.5.Foreign body reactions.6.Allergic-type reactions to pla (poly lactic acid) materials (plla (poly-l-lactic acid), pldla (poly-l-d-lactic acid)) have been reported.These reactions have sometimes necessitated the removal of the implant.Patient sensitivity to device materials must be considered prior to implantation.7.Silicone sensitivity, though very rare, has been reported.Directions for use dfu-0350 fiberlock¿ suspension system.C.Contraindications.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.D.Adverse effects 1.Infections, both deep and superficial.2.Foreign body reactions.The complaint was not confirmed, as no evidence of the reported failure was received.

• Brand Name: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Common Device Name: WASHER, BOLT, NUT
• 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: 22665985
• Report Number: 1220246-2025-03152
• Device Sequence Number: 7533562
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: 00888867048966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Device Catalogue Number: AR-8919DS
• Device Lot Number: 15320709
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/26/2025; 11/07/2025
• 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: Required Intervention
• Patient Sex: Unknown