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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
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 (b)(6) 2024, it was reported by a distributor via (b)(4) that an ar-1318ft suture anchor broke.This occurred during a procedure after predrilling with the larger of the 2 k-wires the surgeon went to insert the anchor on the patient with a dense cortical bone.The surgeon got the anchor about 70% inserted, and the screwdriver tip collapsed, they withdrew the driver, and as the tip had collapsed, the slot where the needles/stitches normally pass was unable to be delivered through the tip and in doing so the sharpened end of the driver cut these threads leaving only the anchor partially inserted.After the stitch became unusable, the team attempted to use the driver to remove the partially inserted anchor and the screwdriver tip broke off.The team was able to retrieve the anchor with a needle driver as it was still proud.They then re-drilled and used a second anchor, which worked in the typical fashion.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Correction: d2a.

• 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: 20358130
• Report Number: 1220246-2024-07958
• Device Sequence Number: 15246588
• Product Code: MBI
• UDI-Device Identifier: 00888867008519
• UDI-Public: (01)00888867008519(11)210714(17)260630(10)13722697
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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 Expiration Date: 06/30/2026
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 13722697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 06/10/2025; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 07/07/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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