MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP S-TAK 2.4X 12MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP S-TAK 2.4X 12MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On(b)(6) 2023, it was reported by an arthrex employee via email that an ar-1934bcf-24-2 biocomposite suturetak anchor pulled out of the implantation site.This was discovered during a procedure on (b)(6) 2023.The case was completed using a new product.Additional information received on (b)(6) 2023: this was discovered during a labral repair procedure.
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.
Additional Manufacturer Narrative
Additional information.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 misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: BIO-COMP S-TAK 2.4X 12MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17417785
• Report Number: 1220246-2023-07355
• Device Sequence Number: 12558288
• Product Code: MAI
• UDI-Device Identifier: 00888867023918
• UDI-Public: 00888867023918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091844
• 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): 02/07/2025

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 Expiration Date: 08/31/2026
• Device Model Number: BIO-COMP S-TAK 2.4X 12MM
• Device Catalogue Number: AR-1934BCF-24-2
• Device Lot Number: 15004702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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