MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
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 4/7/2025, it was reported by a facility representative via email that ar-1318ft corkscrew ft sutures did not seat on bone.This was discovered during a procedure.Additional information received on 5/6/2025: this was discovered during a tenorrhaphy for laceration central band ipp d2drt procedure on (b)(6) 2025.The anchor failed when it was attempted to be fixed in the patient's bone.The threads of the screwdriver did not bite into the bone.The anchor was removed; however, nothing broke inside the patient.The case was completed using a new ar-1318ft corkscrew ft.The case was delayed about five minutes, but no additional anesthesia was needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1318ft, suture anchor, corkscrew®, ft, micro, 2.2 mm with one #2-0 fiberwire® and two needles, batch 15292571, was received for investigation.Visual evaluation noted that the anchor's threads were damaged, and the system was returned disassembled.Functional testing was not performed due to damage to the device.The most likely cause is attributed to misuse due to misaligned insertion and prying/leveraging the device during use.Complaint allegation is confirmed.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• 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: 22104837
• Report Number: 1220246-2025-02274
• Device Sequence Number: 17960945
• Product Code: MBI
• UDI-Device Identifier: 00888867008519
• UDI-Public: (01)00888867008519(11)240724(17)290630(10)15292571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 15292571
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown