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	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/26/2025, an fda medwatch notification was received via email.A facility representative reported that a piece of the guide pin, from an ar-1789j-cp internalbrace implant system, broke off inside the patient¿s left knee.When the guide pin was removed, it was found to be bent.This issue was identified during the procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), photographs, videos, event descriptions, and additional field data, arthrex was able to determine the most likely cause of the reported issue.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 7/2/2025: this was discovered during an arthroscopy with open medial collateral ligament repair procedure.During the procedure, the broken fragment was not removed, nor was it addressed in a subsequent surgery.

• 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: 22555589
• Report Number: 1220246-2025-02989
• Device Sequence Number: 9681662
• Product Code: MAI
• UDI-Device Identifier: 00888867318144
• UDI-Public: (01)00888867318144(11)240917(17)260731(10)15318598
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

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: 07/31/2026
• Device Model Number: IB KIT, PLUS, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1789J-CP
• Device Lot Number: 15318598
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 10/16/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/28/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown