MAUDE Adverse Event Report: ARTHREX, INC. 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 5/6/2024 a sales representative reported via phone that an ar-8934bcst-2 3.0 3.0 double loaded suturetape s-tak assy cracked when tapping in the bone.All fragments were retrieved from the patient with a slight delay.The case was completed using another ar-8934bcst-2 3.0 3.0 double loaded suturetape from an unknown lot with no issues.This was discovered during an achilles repair procedure on (b)(6) 2024, with no reported patient harm.
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 user error due to misaligned insertion and/or improper bone preparation.
Additional Manufacturer Narrative
Correction: d2a, d2b.

• Brand Name: 3.0 DOUBLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 19447712
• Report Number: 1220246-2024-04716
• Device Sequence Number: 8544947
• Product Code: MAI
• UDI-Device Identifier: 00888867375123
• UDI-Public: 00888867375123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2025

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: 15086335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/04/2025; Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/25/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown