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 02/13/2024

Event Type  malfunction  

Event Description

On 03/18/2024, it was reported by a distributor via sems that a total of 3 qty of ar-3638 fibertak were faulty - 1 of the 3 affected fibertac anchor handle was found to be crooked and 2 of the 3 affected fibertac anchor handle broke during the procedure.In the course of the procedure, a total of five 1.8 knotless fibertak suture anchors were opened.For the first two anchors, the straight drill was used and both anchors were implanted successfully.Starting from the third anchor, the surgeon switched to the curved drill guide.For the 3rd anchor, the anchor handle was found to be crooked but intact after removal and the suture anchor was later pulled out during the suture shuttling process.For the 4th anchor, after drilling and during the mallet-in process, resistance was encountered and it can be seen under the arthroscopy that the handle was already crooked, the anchor was later pulled out when the surgeon tried to set the anchor.One tip of the handle was lost.For the 5th anchor, the drill guide wobbled slightly after drilling, and the drill track might have been lost so greater resistance was encountered when malleting in the 5th anchor, both tips of the handle were lost and the anchor was also pulled out when the surgeon tried to set the anchor.It was the surgeon¿s first attempt to use knotless 1.8 fibertak anchor, therefore the failure may be due primarily to the unfamiliarity with the drilling and suture shuttling of the all-suture anchor.For preventive measures, it is suggested that the new users undergo a saw bone training session with the sales team prior to the procedure.Getting familiar with the anchor deployment and suture shuttling process on saw bone is likely to ensure the successful implantation of the anchor.Update 03/20/2024: it was informed that surgeon took post-op x-ray and found out that the tips were left inside the patient's body but decided not to remove any of the broken parts.There were also no side effect reported nor revision surgery required.It was also informed that there is no need for regulatory report but an investigation letter was required by the hospital.

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: 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: 18952577
• MDR Text Key: 338313194
• Report Number: 1220246-2024-01616
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: 00888867362871
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K221396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 15044877
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2023
• 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