MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2025
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 20th june 2025, it was reported by an arthrex employee via email that for an ar-2323bcc, suture anchor, biocomposite swivelock® c, 5.5 mm x 19.1 mm, closed eyelet, initially ar-8980p-1, dx swivelock®, 4.75 mm x 16.1 mm, peek, was inserted, the surgeon expressed concern about inadequate fixation and removed the implant.The 5.5 swivelock was discussed and accepted as an alternative.(hospital shelf stock).Due to the absence of a scout nurse, the implant was retrieved and opened without checking the expiry date by the arthrex sales rep.The implant was partially inserted before the expiry date was noticed.(suture loaded and eyelet at hole).The surgeon was immediately informed and chose to proceed with the expired implant, acknowledging the expiry for documentation purposes.The sales rep informed the regional sales manaer post op and sports rep onsite who discussed the event with the hospital staff and surgeon.This was detected during use in an ankle reconstruction atfl ib procedure on (b)(6) 2025.The procedure was completed successfully as the expired implant was implanted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
• 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: 22336808
• Report Number: 1220246-2025-02658
• Device Sequence Number: 9126632
• Product Code: MAI
• UDI-Device Identifier: 00888867319912
• UDI-Public: (01)00888867319912(11)241016(17)290930(10)15332684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/14/2025

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: SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
• Device Catalogue Number: AR-8980P-1
• Device Lot Number: 15332684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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
• Patient Sex: Unknown