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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/01/2025, a sales representative reported via email that the eyelet of the 3.5 swivelock in the ar-1788j-cp internal brace implant system broke during insertion.They drilled with the hard bone drill and used the correct tap to prep the implant.They had to open another kit to replace the broken swivelock to complete the procedure.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 07/10/2025.Additional information was received on 7/15/2025: a lateral ankle procedure with internal brace and brostrom repair was being performed.The surgery was completed using another ar-1788j-cp internal brace implant system.The procedure experienced a brief delay of a few minutes while a new kit was obtained.No additional anesthesia was administered.The eyelet experienced breakage during the event; however, all fragments were successfully retrieved, and no adverse effects or significant damage were reported postoperatively.
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 device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22584072
• Report Number: 1220246-2025-03032
• Device Sequence Number: 14578233
• Product Code: MAI
• UDI-Device Identifier: 00888867318137
• UDI-Public: (01)00888867318137(11)250611(17)270331(10)15450251
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/05/2025

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: 15450251
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown