MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2024

Event Type  malfunction  

Event Description

On 02/09/2024, it was reported by a sales representative via phone that an ar-8991ds disposables kit for dx knotless fibertak was found to have a hair upon opening.A second ar-8991ds kit was used with (2) ar-8991 fibertak® dx suture anchors, which broke.This occurred during use in a case while inserting the anchors the anchor inserter broke.The fragments were not retrieved.The case was completed using the internal brace anchor to complete the repair.The patient had moderate bone quality.

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.

• Brand Name: DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK
• 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: 18799419
• MDR Text Key: 336475770
• Report Number: 1220246-2024-01178
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK
• Device Catalogue Number: AR-8991DS
• Device Lot Number: 14173973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2021
• 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