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

Model Number	IB KIT, BC, W/ CC FT AND JUMPSTART
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/29/2025, an fda medwatch notification was received via email.A facility representative reported that a patient was scheduled for a right ankle lateral ligament repair.During the procedure, the team utilized an internalbrace implant system ar-1788j-cp.One of the guidewires broke off in the patient's talus bone due to the bone being extremely hard.Attempts to remove the guidewire were unsuccessful.It was noted that further efforts to retrieve the wire could have created a deficit in the bone, potentially preventing completion of the procedure.The guidewire was left in place, with no portion protruding that could cause further injury.This was discovered during a ligament repair procedure in (b)(6) 2025.Additional information was received on 11/05/2026: on (b)(6) 2025, a right ankle lateral ligament repair was performed.The surgeon elected to leave the pin in place and redirected the drill hole slightly more proximally and posteriorly.Drilling was conducted under c-arm guidance to confirm there was no intra-articular penetration.The drill hole was then tapped, and a swivelock anchor with internal brace was placed, achieving excellent fixation.The procedure was delayed due to attempts to retrieve broken guidewires from the surgical site.Additional anesthesia was administered; however, the exact duration is uncertain.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported and observed failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking or being damaged.Directions for use dfu-0087-eo revision 5, corkscrew®, pushlock®, and swivelock® suture anchors 1.Insufficient quantity or quality of bone.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: IB KIT, BC, W/ CC FT AND JUMPSTART
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 23646952
• Report Number: 1220246-2025-05190
• Device Sequence Number: 9961293
• Product Code: MAI
• UDI-Device Identifier: 00888867318137
• UDI-Public: (01)00888867318137(11)240404(17)260228(10)15229892
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 03/06/2026

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: 02/28/2026
• Device Model Number: IB KIT, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1788J-CP
• Device Lot Number: 15229892
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown