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

Model Number	SUTR ANCH,CRKSCRW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/16/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1915sf suture anchor had an issue releasing the wire base causing it to break.This occurred during a procedure and the fragment was left in the malleolus.
Event or Problem Description
On 05/16/2024 additional information was received by an arthrex subsidiary employee via email who stated that the procedure performed was a medial malleolus fracture.Photos were taken and are attached.The patient's bone quality was rigid.A 2.4mm drill tip guide wire was used to prepare the bone socket for insertion.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image from the field, it is evident that the device's tip broke off.Consequently, arthrex was able to conclude the most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging during use.

• 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: 19279757
• Report Number: 1220246-2024-03044
• Device Sequence Number: 18059625
• Product Code: HWC
• UDI-Device Identifier: 00888867022652
• UDI-Public: 00888867022652
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/12/2025

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-1915SF
• Device Lot Number: 15155741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/18/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 12/19/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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