MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK CORKSCREW FT; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTURE ANCHOR, PEEK CORKSCREW FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 7th august 2025, it was reported by an arthrex's employee via email that for 1 unit of ar-1927psf-45, 4.5 mm peek corkscrew® ft suture anchor with one #2 fiberwire® and one # 2 tigerwire®, it broke while using it.This was detected during an arthroscopic acromioplasty/cuff repair right shoulder on (b)(6) 2025.The case was completed successfully by opening another implant.
Event or Problem Description
Additional information: there is no patient harm.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is not confirmed.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 quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTURE ANCHOR, PEEK CORKSCREW FT
• Common Device Name: NON-DEGRADABLE FIXATN 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: 22794046
• Report Number: 1220246-2025-03469
• Device Sequence Number: 12833773
• Product Code: MBI
• UDI-Device Identifier: 00888867023666
• UDI-Public: (01)00888867023666(11)241111(17)291031(10)15345467
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K061863
• 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): 10/30/2025

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: SUTURE ANCHOR, PEEK CORKSCREW FT
• Device Catalogue Number: AR-1927PSF-45
• Device Lot Number: 15345467
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown