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

Model Number	IOBP HIP OPEN TIP PROCEDURE KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/03/2025, a sales representative reported via (b)(4) that an abs-2010-ot intraosseous bioplastys tip of the decompression device broke.This occurred during a hip iobp procedure on (b)(6) 2024, when the device broke off inside the patient and could not be retrieved.
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, h11 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 is misuse due to the excessive force used to pry and/or leverage the device.

• Brand Name: IOBP HIP 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: 21409583
• Report Number: 1220246-2025-00526
• Device Sequence Number: 18477834
• Product Code: FMF
• UDI-Device Identifier: 00888867338548
• UDI-Public: (01)00888867338548(11)221121(17)271031(10)15026040
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121124
• 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): 08/25/2025

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: IOBP HIP OPEN TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2010-OT
• Device Lot Number: 15026040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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