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	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/25/2025, a sales representative reported via (b)(4) that an abs-2010-ot intraosseous bioplasty kit had the tip of the decompression device broken off when trying to remove it from the patient's hip.The surgeon was unable to remove the broken tip, which stayed in the patient's bone.They were able to complete the remainder of the procedure.This was discovered during a core decompression procedure on (b)(6) 2025.Additional information has been requested.
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.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 excessive user-applied mechanical forces.

• 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: 21584644
• Report Number: 1220246-2025-00891
• Device Sequence Number: 8832749
• Product Code: FMF
• UDI-Device Identifier: 00888867338548
• UDI-Public: (01)00888867338548(11)240712(17)290630(10)15287052
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/27/2025

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: 15287052
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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