MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.
Event or Problem Description
On 5/27/2022, it was reported by a sales representative via phone that an ar-1938ps peek suture tak was implanted into the patient and while tensioning, the sutures broke.The sutures were cut and the anchor portion remains in the patient.Surgeon opened an ar-2923bc biocomposite pushlock to continue with the repair; however, anchor broke inside the patient during insertion.Surgeon was able to retrieved all the broken fragments.Another ar-2923bc biocomposite pushlock was opened and case was completed successfully without further issues.This was discovered during a labral repair on (b)(6)2022.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19012509
• Report Number: 1220246-2024-01751
• Device Sequence Number: 3879678
• Product Code: MAI
• UDI-Device Identifier: 00888867024229
• UDI-Public: 00888867024229
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• 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
• Report Date (Section B): 04/01/2024

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: 11/30/2022
• Device Model Number: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS
• Device Lot Number: F181771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2017
• 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