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 Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-1788j-cp internalbrace implant system 2.7 drill bit broke into multiple pieces while drilling in the sustentaculum tali of the calc over top of the 1.1mm k-wire that came in the ib kit.The bone was not abnormally hard, and the surgeon was drilling in line with the k-wire.There were no other implants they were hitting.They retrieved as many pieces of the drill bit as possible, used another 1.1mm k-wire to drive in another spot in the calc, and used the 3.4 mm drill bit, which then broke the k-wire off in the bone.The case was completed successfully.This was discovered during a spring ligament internal brace procedure on (b)(6) 2025.Additional information was received on 02/11/2025: the k-wire that broke in the bone was not retrieved from the patient and was buried in the bone; therefore, the surgeon was fine leaving it implanted.There is no revision surgery needed.The case was completed using the spring ligament ib technique using the ar-1788j-cp internalbrace implant system.The only difference was they used a 3.4 drill for the 3.5 anchor because the 2.7 crumbled.It is unknown if additional anesthesia was administered, but the case was delayed 30 minutes.There was no report of the patient suffering any adverse effects or significant damage on or after the surgery.
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.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion or prying/leveraging the device during insertion.

• 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: 21444614
• Report Number: 1220246-2025-00603
• Device Sequence Number: 7159138
• Product Code: MAI
• UDI-Device Identifier: 00888867318137
• UDI-Public: (01)00888867318137(11)250121(17)261130(10)15375813
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/05/2025

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 Model Number: IB KIT, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1788J-CP
• Device Lot Number: 15375813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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