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	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 4/18/2025, an fda medwatch notification was received via email.A facility representative reported that the tip of a flipcutter from an abs-2010-ot intraosseous bioplasty core decompression delivery kit broke off.The surgeon attempted removal and could not, ultimately determine that leaving the broken tip in the femoral head was the best course of action.The procedure was successfully completed without any further complications on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received on 5/7/2025: this was discovered during a right femoral head core decompression procedure for avascular necrosis.The case was completed using another abs-2010-ot intraosseous bioplasty core decompression delivery kit.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or improper surgical technique.The complaint allegation was not confirmed.No evidence of the failure was received.

• 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: 21951266
• Report Number: 1220246-2025-01864
• Device Sequence Number: 8691776
• 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: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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?: No
• Distributor Facility Aware Date: 04/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 09/16/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/30/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown