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

Model Number SELF BUNCHING KL 1.8 FIBERTAK, HIP

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

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.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 03/04/2024, it was reported by a sales representative via e-mail that (2) ar-3636h self bunching 1.8 knotless hip fibertak®soft anchors failed.This occurred during a hip scope after drilling for an anchor of the 1.8 hip fibertak (per technique), during insertion of the first ar-3636h, the inserter bent, not allowing implantation.The second time inserter completely broke free, forcing the physician to dislodge the tip of the inserter from the patient.The drill and drill guide was switched out after this.Additional information provided 3/5/24: a 1.8 drill from the disposable kit was used to create socket (ar-3600dhs/sn (b)(6)).The patient had normal bone quality.All fragments were retrieved from the patient.

• Brand Name: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• 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: 18905058
• MDR Text Key: 337698237
• Report Number: 1220246-2024-01470
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: 00888867362888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203268
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Device Catalogue Number: AR-3636H
• Device Lot Number: 152044114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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