MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, PEEK, SUTURETAPE, 4.75M; BONE FIXATION SCREW/PLATE

Model Number	CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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 2/19/2025, it was reported by a sales representative via email that an ar-1927pst-475 peek corkscrew ft broke during insertion.The anchor broke with three threads remaining, not in the bone.The rest of the anchor remained intact and was inserter until the loop holding the 1.3 mm sutures was buried below the level of the bone.The threads were then removed but had broken into smaller pieces.This was discovered during an rcr procedure on (b)(6) 2025.Additional information requested on 2/26/2025.
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 misaligned insertion or prying/leveraging the device during insertion.

• Brand Name: CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
• 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: 21517599
• Report Number: 1220246-2025-00783
• Device Sequence Number: 18565963
• Product Code: HWC
• UDI-Device Identifier: 00888867237872
• UDI-Public: (01)00888867237872(11)241023(17)290930(10)15336210
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927PST-475
• Device Lot Number: 15336210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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