MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM KNOTLESS SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number 3.0MM KNOTLESS SUTURETAK

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/26/2024

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.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 02/28/2024, it was reported by a sales representative via email that (2) ar-8934bck knotless suturetak sutures pulled out of the anchors and frayed.The surgeon could no longer shuttle or tension the anchor.The surgeon drilled out the anchors and used to new ones to complete the case.This was discovered during a deltoid repair procedure on (b)(6) 2024.Additional information provided 3/5/24: the 3.0mm suturetak disposable kit was used to prepare the bone socket.The patient had good bone quality.The case was slightly delayed but by no more than 5 minutes.Additional anesthesia was not administered.The patient did not suffer any negative effects.

• Brand Name: 3.0MM KNOTLESS SUTURETAK
• 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: jared engle ; 8009337001
• MDR Report Key: 18934644
• MDR Text Key: 338037377
• Report Number: 1220246-2024-01549
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: 00888867380981
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 3.0MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-8934BCK
• Device Lot Number: 14946099
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• 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