MAUDE Adverse Event Report: ARTHREX, INC. FIBERLOCK SUSPENSION SYSTEM; NON-DEGRADABLE FIXATION FASTENER

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)
Date of Event	04/10/2025
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 07/25/2025, it was reported by the patient via phone that they had undergone a left-hand tightrope cmc joint arthroplasty suspension procedure on (b)(6) 2025, during which an ar-8988-cp fiberlock suspension system was implanted.At approximately six weeks post-surgery, the patient began experiencing symptoms consistent with complex regional pain syndrome (crps) in the left hand near the site of implantation.The patient expressed concern that their body may be rejecting the implanted material, citing a history of hypersensitivity to products and a known allergy to metals.Both the patient and surgeon are aware that the ar-8988-cp product does not contain metallic components.Currently, the complication is being managed with two steroid injections administered to the affected left hand and ongoing occupational therapy.The surgeon confirmed via x-ray that the thumb has healed properly and appears normal.At this time, the need for further surgical intervention remains undetermined, and the patient's dermatologist requested to conduct a scratch test specific to the arthrex product.The patient also inquired whether arthrex could provide a small product sample for the allergy testing.
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.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: FIBERLOCK SUSPENSION SYSTEM
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: 22773868
• Report Number: 1220246-2025-03413
• Device Sequence Number: 13041584
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: (01)00888867377875(11)250127(17)291231(10)15378448
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: FIBERLOCK SUSPENSION SYSTEM
• Device Catalogue Number: AR-8988-CP
• Device Lot Number: 15378448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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