MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/31/2025
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 02/25/2025, an arthrex subsidiary employee reported via (b)(4) that an ar-1928snf-2 suture anchor does not fit snugly, and when you try to introduce it further, the sutures grind, leaving the anchor without them.This occurred during a lateral plasty procedure that was completed using a new corkscrew 5.5.
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 can be attributed misuse due to misaligned insertion; or prying/leveraging the anchor during insertion.
Event or Problem Description
Additional information was provided on 03/05/2025 where the arthrex subsidiary employee reported that nothing was used for the preparation of the bone.The patient had normal bone quality.The fiberwire sutures that come in the anchors were broken, leaving the head inside the patient.It was removed with a chisel and hammer.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.

• Brand Name: SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 21592644
• Report Number: 1220246-2025-00908
• Device Sequence Number: 20920170
• Product Code: HWC
• UDI-Device Identifier: 00888867023789
• UDI-Public: (01)00888867023789(11)240430(17)290331(10)15241802
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 09/22/2025

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,CRKSCRW FT II 5.5X 16.3MM
• Device Catalogue Number: AR-1928SNF-2
• Device Lot Number: 15241802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 03/05/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 09/12/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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