MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
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 15th may 2025, it was reported by an arthrex employee via email that for an ar-1320bcnf, suture anchor, micro biocomposite suturetak® 2.4 x 6.5 mm with 2-0 fiber wire® with two taper point needles, its anchor broke during insertion.This was detected during a repair surgery for anterior talofibular ligament injury of the ankle joint surgery on (b)(6) 2025.The was completed successfully by using a new ar-1320bcnf.There was no patient harm and no secondary procedures needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1320bcnf serial/batch: (b)(6) was received for evaluation.Functional testing was not performed as the device was received damaged.Visual inspection revealed that the implant was not returned for evaluation.The sutures were broken and frayed with damage along the suture strand.The most likely cause of the reported and observed device failure is user error.Applying excessive force during use can damage the anchor and prevent the device from functioning as intended.Refer to the investigation pictures.The complaint allegation was confirmed.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22123281
• Report Number: 1220246-2025-02334
• Device Sequence Number: 4122594
• Product Code: MAI
• UDI-Device Identifier: 00888867009813
• UDI-Public: (01)00888867009813(11)240521(17)280430(10)15251834
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 15251834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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