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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.
Event or Problem Description
It was reported that the surgeon opened the ar-1787pj-cp mini internal brace kit to do an internal brace for an aitfl.The first anchor (3.5 sl w/ fibertape) out of the kit was implanted as designed.When the second anchor was loaded and inserted the screw would not seat all the way.The rep reported upon inspection it looks like the metal sheath was not pressed into the black plastic paddle far enough resulting in the eyelet not reaching the bottom of the tunnel causing the anchor to not fully seat.The surgeon opened a 4.75 peek swivelock (ar-2324pslc) to use in place of the damaged 3.5 swivelock and completed the case as scheduled.See attached images.

• 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: 19483926
• Report Number: 1220246-2024-05199
• Device Sequence Number: 20840687
• Product Code: MAI
• UDI-Device Identifier: 00888867295629
• UDI-Public: 00888867295629
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 06/07/2024

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, MINI, PEEK, CC FT, W/ JUMPSTART
• Device Catalogue Number: AR-1787PJ-CP
• Device Lot Number: 12486023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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