MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT,3.5X 10MM; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW FT,3.5X 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 07/28/2025, a sales representative reported via phone that an ar-1915ft suture anchors inserter broke off.This occurred during a case, they suspected the patient had hard bone quality and drilled a hole that was a bit larger using a 2.7mm drill.A portion of the anchor was half way in and remains in the patient.A larger hole was drilled using a 3.0 mm drill and an additional ar-1915ft suture anchor was used to complete the case.There was approximately a five minute delay in which it is uncertain if additional anesthesia was administered.There was no harm on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• 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: 22792310
• Report Number: 1220246-2025-03447
• Device Sequence Number: 18335724
• Product Code: HWC
• UDI-Device Identifier: 00888867022607
• UDI-Public: (01)00888867022607(11)240620(17)290531(10)15276224
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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,3.5X 10MM
• Device Catalogue Number: AR-1915FT
• Device Lot Number: 15276224
• 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: 12/04/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown