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 2/28/2024, it was reported by a sales representative via email that ar-8934bck knotless suturetak pulled out.The anchor remained in bone, but the sutures pulled through.The case was completed using fibewire to complete the case.This was discovered during an atfl procedure on (b)(6) 2024.Additional information provided 3/4/24: the 3.0 suturetak disposable kit was used to prepare the bone socket.The patient's bone quality was good.No delay in the case.Additional anesthesia was not needed.The patient didn't suffer 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: 18934259
• MDR Text Key: 338078340
• Report Number: 1220246-2024-01547
• 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