MAUDE Adverse Event Report: ARTHREX, INC. 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2024
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 9/12/2024, it was reported by a sales representative via email that an ar-8934bcst-2 double loaded suturetape s-tak assy tip of the anchor broke.This was discovered during a brostrom procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 9/26/2025: the surgeon drilled a bone hole, inserted the suturetak, malleted it in, and the suturetak broke.All the broken fragments were removed from the patient.The case was completed by using another ar-8934bcst-2 double loaded suturetape s-tak assy.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8934bcst-2 serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the anchor of the device is broken.The most likely cause is attributed to misuse due to prying/leveraging the device during insertion.

• Brand Name: 3.0 DOUBLE 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: 20280059
• Report Number: 1220246-2024-07808
• Device Sequence Number: 7545963
• Product Code: HWC
• UDI-Device Identifier: 00888867375123
• UDI-Public: (01)00888867375123(11)240307(17)280229(10)15217243
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• 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): 01/27/2025

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: 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST-2
• Device Lot Number: 15217243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided; 01/02/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/09/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2024
• 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