MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNEE FIBERTAKS; ORTHOPEDIC MANUAL SURG INSTR

Model Number DISPOSABLE KIT, KNEE FIBERTAKS

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 02/26/2024, it was reported by a sales representative via (b)(4) that an ar-3710 disposable fibertak anchor pulled out.This occurred during use in a case with no patient effect.Both anchors came out of the bone while the surgeon was tensioning the loop suture to the ligament.A separate disposable kit was utilized for each anchor due to a drop on the sterile field.

• Brand Name: DISPOSABLE KIT, KNEE FIBERTAKS
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18923116
• MDR Text Key: 337891938
• Report Number: 1220246-2024-01530
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867426016
• UDI-Public: 00888867426016
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISPOSABLE KIT, KNEE FIBERTAKS
• Device Catalogue Number: AR-3710
• Device Lot Number: 15178864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2023
• 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