MAUDE Adverse Event Report: ARTHREX, INC. SWVLK PEEK TENO 8MM W/FORK EYELET; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWVLK PEEK TENO 8MM W/FORK EYELET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 12/9/2024, it was reported by an arthrex subsidiary employee via email that an ar-1662psl-8 swivelock tenodesis, peek got damaged; although, it did not hit anything during insertion.This was discovered during a procedure on (b)(6)2024.The case was completed using another ar-1662psl-8 swivelock tenodesis, peek.Additional information received on 12/17/2024: this was discovered during a biceps tenodesis.The eyelet of the swivelock got damaged during insertion and all the broken fragments were removed along with the anchor.The case was not delayed, and additional anesthesia was not needed.
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 user error of the device due to excessive force being used during insertion of the implant.

• Brand Name: SWVLK PEEK TENO 8MM W/FORK EYELET
• 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: 21067828
• Report Number: 1220246-2025-09191
• Device Sequence Number: 16998675
• Product Code: MAI
• UDI-Device Identifier: 00888867020658
• UDI-Public: (01)00888867020658(11)211129(17)261031(10)14636321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: SWVLK PEEK TENO 8MM W/FORK EYELET
• Device Catalogue Number: AR-1662PSL-8
• Device Lot Number: 14636321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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