MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK C,4.75X19.1MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Numbness (2415)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 04-feb-2026, it was reported by a sales representative via phone that an ar-2324pslc peek swivellock was used in a loop and tak tendonesis on (b)(6) 2025 and completed procedure successfully.The patient complained 9 weeks after surgery of numbness.Patient was negative for dvt and was diagnosed with ulnar neuritis.Patient complains of upper extremity pain and self-diagnosed discoloration.Patient requested a sample of the peek swivellock to be sent to the allergist for testing.Patient has been frequently complaining of various non-anatomically related pain and discomfort.No revision surgery has been scheduled.
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.The complaint device was not received for evaluation.Based on the information provided, including the returned device (when available), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is a patient-specific biological response.The applicable directions for use (dfu-0087-eo) identify potential adverse events that may occur.The reported failure may also be the result of one or a combination of the following factors: 1.Insufficient quantity or quality of bone.2.Foreign body sensitivity.3.Blood supply limitations and previous infections, which may retard healing.4.Active infections.5.Conditions that limit the patient¿s ability or willingness to restrict activities or follow postoperatively instructions during the healing period.Directions for use - dfu-0087-eo revision 6- corkscrew, pushlock, and swivelock suture anchors.C.Contraindications: 1.Insufficient quantity or quality of bone.2.Blood supply limitations and previous infections, which may retard healing.3.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.5.Any active infection or blood supply limitations.6.Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• 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: 24393271
• Report Number: 1220246-2026-00680
• Device Sequence Number: 10257892
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)241004(17)290930(10)15327151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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 Model Number: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15327151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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