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

Model Number	IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024, it was reported by a sales representative via phone that an ar-1787pj-cp internal brace kit 2.7 drill bit broke when drilling into the talus.This occurred during use in a case with no patient effect.Case completed using a different 2.7 drill bit.All fragments not removed, one shard was found in x-ray but will not affect patient.Delay in case 5 minutes.
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 user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: IB KIT, MINI, PEEK, CC FT, W/ 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: 20158151
• Report Number: 1220246-2024-07427
• Device Sequence Number: 18241853
• Product Code: MAI
• UDI-Device Identifier: 00888867295629
• UDI-Public: 00888867295629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/07/2025

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, MINI, PEEK, CC FT, W/ JUMPSTART
• Device Catalogue Number: AR-1787PJ-CP
• Device Lot Number: 15258210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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