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	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-1915ft corkscrew ft u-shape prongs broke during insertion of the anchor.All broken fragments were removed from inside the patient and the case was completed successfully.This was discovered during a brostrom procedure on (b)(6) 2023.Additional information received on (b)(6) 2023: the case was completed using a new ar-1915ft corkscrew ft.Pliers were used to turn the corkscrew in reverse and remove it.Additional anesthesia was administered to make up for the ten-minute delay.The patient suffered no negative effects on or after the procedure.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual evaluation identified that the tip at the distal end of the driver had broken off.No broken pieces were returned for investigation.Functional testing was not performed due to the damage to the device.Within the screw during use.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18415374
• Report Number: 1220246-2023-09677
• Device Sequence Number: 14186048
• Product Code: HWC
• UDI-Device Identifier: 00888867022607
• UDI-Public: 00888867022607
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/09/2025

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: 15127629
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 06/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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