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

Model Number	PEEK, SWIVELOCK FT, 4.75X19.1MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 22nd july 2025, it was reported by an arthrex employee via email that an ar-2324pct-1, suture anchor, peek swivelock®, 4.75 mm with closed peek eyelet and blue fibertape® loop, was not inserting.This was detected during use in a rotator cuff repair procedure on (b)(6) 2025.The procedure was completed successfully with a new anchor.
Event or Problem Description
15th august 2025 - the complaint initiator replied regarding the defect that the swivelock would not engage on the cortical bone.The eyelet remained in the patient and proved difficult to remove.
Additional Manufacturer Narrative
Additional information: b5, 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 user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.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: PEEK, SWIVELOCK FT, 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: 22736703
• Report Number: 1220246-2025-03302
• Device Sequence Number: 20632703
• Product Code: MAI
• UDI-Device Identifier: 00888867098114
• UDI-Public: (01)00888867098114(11)250609(17)300531(10)15448760
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCT-1
• Device Lot Number: 15448760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown