MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, W/ CC FT AND JUMPSTART; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IB KIT, PEEK, W/ CC FT AND JUMPSTART
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
Holf nh 4/17 on (b)(6) 2023, it was reported by a facility representative via sems that a drill bit from an ar-1788pj-cp internalbrace implant system broke within the patient's talus.Fluoroscopic x-rays were taken, which demonstrated complete intraosseous fragmentation of the tip of the drill bit.Upon direct visualization of the drill bit, it was noted to be completely intraosseous at the talus site.The internal cannulation was not intact, so the surgeon could not remove it with a reverse-threaded hardware removal instrument.The surgeon also elected against putting a trephine over the top to remove it.It's believed this could create more damage and a larger hole in the talus which would not provide any additional benefit and may potentially increase risk.This was discovered during a right ankle anterior talofibular ligament repair with internalbrace and arthroscopy with debridement procedure on (b)(6) 2023.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photos.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 misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: IB KIT, PEEK, W/ CC FT AND JUMPSTART
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16751865
• Report Number: 1220246-2023-06540
• Device Sequence Number: 8627385
• Product Code: MAI
• UDI-Device Identifier: 00888867218208
• UDI-Public: 00888867218208
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Model Number: IB KIT, PEEK, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1788PJ-CP
• Device Lot Number: 14946949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown