MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; NON-DEGRADABLE FIXATN FASTENER

Model Number SUTR ANCHBIO-COMP S-TAK KNOTLESS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2023

Event Type  malfunction  

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 Description

On 9/26/2023, it was reported by a facility representative via email that ar-1938bc biocomposite suturetak and an ar-3636 knotless fibertak anchors pulled out.This was discovered during a procedure on (b)(6) 2023.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17996188
• MDR Text Key: 326390870
• Report Number: 1220246-2023-08337
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/24/2023

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
• Device Operator: Health Professional
• Device Model Number: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Device Lot Number: 15008176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1