MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number SUTR ANCH,PEEK P-LCK,2.9X 12.5MM

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

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 8/16/2023, it was reported by a sales representative via email that an ar-2923ps peek pushlock flag was detached from the pushlock upon opening it.The sutures and anchors appeared normal, so the surgeon inserted the implant.When the pushlock was being unscrewed, it was noticed that the suture tape had been cut, and the anchor eyelet had pulled out of the prepared bone while the anchor itself remained implanted.The eyelet and the broken sutures were retrieved from inside the patient.Another ar-2923ps peek pushlock was opened, and it was noticed again that the flag was not connected.The anchor was not used as the surgeon was not willing to risk the same outcome as the previous anchor.The case was completed with a third ar-2923ps peek pushlock, which had the flag attached.This was discovered during a shoulder labral repair procedure on (b)(6) 2023.Additional information received on 8/30/2023: there was a ten-minute delay while the surgeon was determining whether or not to implant the second faulty anchor and how to continue the case.No additional anesthesia was administered to the patient due to the delay.After the incidents, the procedure was completed successfully.

• Brand Name: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17724771
• MDR Text Key: 323125299
• Report Number: 1220246-2023-07855
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: 00888867028036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 15065266
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/16/2023
• Date Device Manufactured: 03/08/2023
• 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