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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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
It was reported that during a foot surgery while the surgeon screwed down the anchor whereupon the chisel itself breaks off at the front of the top.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update dw 25-jun-2025: further information was provided that the broken part was retrieved out of the patient.
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 for the reported failure can be attributed to misuse due to applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.

• 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: 22511834
• Report Number: 1220246-2025-02892
• Device Sequence Number: 8789031
• Product Code: HWC
• UDI-Device Identifier: 00888867022607
• UDI-Public: (01)00888867022607(11)250127(17)291231(10)15378927
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/13/2025

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 FT,3.5X 10MM
• Device Catalogue Number: AR-1915FT
• Device Lot Number: 15378927
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown