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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is a user such as improper bone preparation, misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.The complaint allegation was not confirmed, the device was not received for evaluation, and no evidence of the product failure was received for evaluation.

• Brand Name: IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART
• Common Device Name: 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
• Report Number: 1220246-2024-01857
• Device Sequence Number: 12227236
• Product Code: MAI
• UDI-Device Identifier: 00888867318144
• UDI-Public: 00888867318144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown