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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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's employee via email that for an ar-1927psf-45, 4.5 mm peek corkscrew® ft suture anchor with one #2 fiberwire® and one # 2 tigerwire®, its anchor broke during insertion and the suture pulled out.This was detected during an open reduction and internal fixation of fractures surgery on (b)(6) 2025.The case was completed successfully by using another new ar-1927psf-45.There was no patient harm, and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1927psf-45 corkscrew® ft suture anchor, batch number 15317446, was received for evaluation.Visual inspection revealed that the anchor's tip was broken and its threads were damaged.The sutures were not returned with the device and, therefore, could not be evaluated.Functional testing was not performed due to the extent of damage to the anchor.Based on the available evidence, the most likely cause of the reported failure is misaligned insertion and/or prying or leveraging of the device during use, which may have compromised the structural integrity of the anchor.The complaint allegation is confirmed based on the physical damage observed.Refer to the attached investigation photos for visual documentation.

• 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: 22749446
• Report Number: 1220246-2025-03353
• Device Sequence Number: 18305645
• Product Code: MBI
• UDI-Device Identifier: 00888867023666
• UDI-Public: (01)00888867023666(11)240916(17)290831(10)15317446
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/20/2025

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: 15317446
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown