MAUDE Adverse Event Report: ARTHREX, INC. IOBP KNEE OPEN TIP PROCEDURE KIT; SYRINGE, PISTON

Model Number	IOBP KNEE OPEN TIP PROCEDURE KIT
Medical Device Problem Codes	Material Fragmentation (1261); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that after procedure, the images of mri showed brightness on the decompression site.The part was not visible in the rx images.The patient felt pain after the surgery.A revision surgery was performed on (b)(6) 2024 to clean the decompression area.A small piece of intraosseous metal was seen.The surgeon suggested it was a part of the decompression device that stayed there.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the available information¿including the returned device (if applicable), photographs, videos, event descriptions, and any additional field data¿arthrex concluded that the most likely cause of the reported failure was user error.This includes misaligned insertion and/or prying or levering the device with excessive force during use, which ultimately resulted in the device breaking.The complaint allegation was confirmed based on the customer's attached x-rays, which noted a piece of possible metal.

• Brand Name: IOBP KNEE OPEN TIP PROCEDURE KIT
• Common Device Name: SYRINGE, PISTON
• 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: 21252019
• Report Number: 1220246-2025-00079
• Device Sequence Number: 21126881
• Product Code: FMF
• UDI-Device Identifier: 00888867338531
• UDI-Public: (01)00888867338531(11)230512(17)280430(10)15092122
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K121124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IOBP KNEE OPEN TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2001-OT
• Device Lot Number: 15092122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown