MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
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 07/29/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1920nsf suture anchor rolled up and sutures already cut.The case was completed using another 5.0 anchor.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the suture of the sutures with needles was damaged and bunched up.Refer to attachments.Based on the information provided which may include pictures and the event description, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error.This failure usually occurs when the anchor is not advancing into the bone, and the driver shaft is spinning inside the anchor causing the sutures to break.

• Brand Name: SUTR ANCH,CRKSCRW
• 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: 22838146
• Report Number: 1220246-2025-03526
• Device Sequence Number: 15764779
• Product Code: HWC
• UDI-Device Identifier: 00888867022751
• UDI-Public: (01)00888867022751(11)240715(17)290630(10)15287857
• 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
• Report Date (Section B): 10/13/2025

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
• Device Catalogue Number: AR-1920NSF
• Device Lot Number: 15287857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown