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	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/28/2024, it was reported by a sales representative via phone that an ar-1788j-cp internalbrace implant system had an issue during an ats lateral ligament reconstruction procedure on (b)(6) 2024.The surgeon was using the 3.4 cannulated drill bit, and after drilling one cycle, the k-wire and the ankle started shaking a bit.The 3.4 cannulated drill bit was removed, and before drilling again in the tibia, the surgeon notice that the tip of the device was broken.X-rays had been taken before and and again afterwards, and no metal piece was found in the talus bone or inside the patient.They were trying to locate a metal piece on the floor, but it could not be found either, so it was assumed that it might have been damaged out-of-box, but had initially not been noticed.Another 3.4 solid drill bit was used to complete the procedure successfully, and there was no harm to the patient.A case delay of 20 minutes was reported, and there was no additional anesthesia administered to the patient.This occurred during use with no patient harm.
Additional Manufacturer Narrative
Additional information.Complaint is confirmed.Visual inspection identified the distal tip of the flutes of the returned drill bit had broken off.No more components from the internalbrace¿ implant system, ligament augmentation repair, biocomposite, with jumpstart® dressing had returned.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed user error due to improper bone prep; misaligned insertion; 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: 18896466
• Report Number: 1220246-2024-01444
• Device Sequence Number: 20380677
• Product Code: MAI
• UDI-Device Identifier: 00888867318137
• UDI-Public: 00888867318137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/04/2024

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: 09/30/2025
• Device Model Number: IB KIT, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1788J-CP
• Device Lot Number: 15170825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• 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