MAUDE Adverse Event Report: ARTHREX, INC. NANO CORKSCREW FT, TI, W 3-0 FW; NON-DEGRADABLE FIXATN FASTENER

Model Number	NANO CORKSCREW FT, TI, W 3-0 FW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
Ar-1317ft suture anchor (lot: 15122984) was used, and once it was released for implantation, the inserter had the titanium anchor falling apart into fragments, which then frayed the suture in that area and had to pull out the suture.The anchor falls into smaller pieces before attempting to take it out.All pieces of the anchor and frayed suture were removed from the patient.An ar-1318ft was used to go up a size to complete the case.The case was delayed less than 15 minutes.No added anesthesia was administered to the patient.No adverse effects on the patient were reported.This was discovered during a scapholunate ligament repair procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/08/2025, it was reported by a sales representative via phone that an ar-1317ft suture anchor (lot: 15122530) when releasing the plastic on the handle for insertion of the anchor, the suture unraveled and had two inches as if it was cut prior and the needle suture were not attached to the anchor.The suture was removed, and the anchor was left in the patient because the inserter would not move counterclockwise out of the patient's bone to retrieve the anchor.The anchor had no breakage, and the surgeon was okay with leaving the anchor in the patient.Then another ar-1317ft suture anchor (lot: 15122984) was used, and once it was released for implantation, the inserter had the titanium anchor falling apart into fragments, which then frayed the suture in that area and had to pull out the suture.The anchor falls into smaller pieces before attempting to take it out.All pieces of the anchor and frayed suture were removed from the patient.An ar-1318ft was used to go up a size to complete the case.The case was delayed less than 15 minutes.No added anesthesia was administered to the patient.No adverse effects on the patient were reported.This was discovered during a scapholunate ligament repair procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and misalignment during insertion.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: NANO CORKSCREW FT, TI, W 3-0 FW
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21891694
• Report Number: 1220246-2025-01675
• Device Sequence Number: 8053193
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: (01)00888867276703(11)230801(17)280731(10)15122984
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180118
• 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,Followup
• Report Date (Section B): 09/23/2025

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: NANO CORKSCREW FT, TI, W 3-0 FW
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 15122984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided; 09/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/24/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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