MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART; BIO SOFT TISSUE FIXATN FASTENR

Model Number IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

On 3/18/2024, it was reported by a sales representative via email that the k-wire from an ar-1789j-cp internalbrace implant system snapped off in the patient.The surgeon was unable to retrieve the broken fragments.The suffered no negative effect, and the case was completed.This was discovered during a procedure.Additional information received on 3/27/2024: this was discovered during a lateral ankle stabilization procedure on (b)(6) 2024.The case was completed using an ar-8991cp dx knotless fibertak implant kit.The case was delayed between thirty to forty-five minutes and additional anesthesia was administered.The patient suffered no negative effects on or after the procedure.

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: IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART
• Type of Device: BIO SOFT TISSUE FIXATN FASTENR
• 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: 19060638
• MDR Text Key: 339632245
• Report Number: 1220246-2024-01857
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867318144
• UDI-Public: 00888867318144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1789J-CP
• Device Lot Number: 15140372
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2023
• 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