MAUDE Adverse Event Report: ARTHREX, INC. KL 1.8 FIBERTAK, SHOULDER; NON-DEGRADABLE FIXATN FASTENER

Model Number KL 1.8 FIBERTAK, SHOULDER

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2024

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.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 03/06/2024, it was reported by a sales representative via email that an ar-3636 knotless 1.8 fibertak soft anchor, gen2, with #2 suture metal rod broke in the glenoid when the surgeon inserted the anchor.The surgeon tried to remove the metal rod but had a hard time, so he ended up cutting out the sutures and the metal remained in the patient but did not cause harm.This was discovered during a bankart procedure.The case was completed by using 3 other knotless fibertaks with different lot numbers.On 03/07/2024, additional information was provided; tried removing the metal rod for around 15-20 minutes.The curved guide was placed on the glenoid before entry, but nothing else was done to prep the bone socket for entry.The bone quality was solid.3 other anchors with different lot numbers worked fine.

• Brand Name: KL 1.8 FIBERTAK, SHOULDER
• Type of Device: NON-DEGRADABLE FIXATN FASTENER
• 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: 18961667
• MDR Text Key: 338469599
• Report Number: 1220246-2024-01655
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: 00888867362871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221396
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KL 1.8 FIBERTAK, SHOULDER
• Device Catalogue Number: AR-3636
• Device Lot Number: 15122488
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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