MAUDE Adverse Event Report: ARTHREX, INC. 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY; BIO SOFT TISSUE FIXATN FASTNR

Model Number	2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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 05/05/2025, a sales representative reported via email that (qty.2) of an ar-1322bcst 2.4 single loaded suturetape had sliding covers to the sutures that would not open.A freer was required to pry them open.Both functioned properly once opened on the back table, sliding open and closed as expected.Additionally, one of the needles on one of the anchors broke during the procedure.All needle fragments were successfully removed from the patient, with confirmation via x-ray.A free needle was used to complete the repair, and the anchor remained in place and was used for the repair.There was no case delay, and no harm was reported to the patient.This was discovered during a lateral ankle stability with brostrum repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 06/02/2025: no adverse effects on or after the surgery were reported, and the repair itself was not affected.
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 prying/leveraging the device during use.

• Brand Name: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• 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: 22109606
• Report Number: 1220246-2025-02282
• Device Sequence Number: 15292746
• Product Code: MAI
• UDI-Device Identifier: 00888867392069
• UDI-Public: (01)00888867392069(11)241227(17)281130(10)15366566
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K140855
• 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): 09/24/2025

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: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-1322BCST
• Device Lot Number: 15366566
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/02/2025; Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/20/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown