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

Model Number	IOBP HIP CLOSED TIP PROCEDURE KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 05/30/2024, it was reported by a sales representative via (b)(4) that an abs-2010-ct intraosseous bioplasty® and an abs-3105 5cc bonesync failed.This occurred while performing a case with bmc mixed with bonesync to fill an acetabular cyst in the hip.They found the spot with the closed-tip delivery system.When injecting the mixture, the surgeon felt a lot of back pressure and thought the bonesync was already hardened.It had only been three minutes at the point since first mixing.They had the doctor remove the mixing syringe containing the bonesync to try to push the inner trochar through the delivery cannula.It was discovered that the white tip on the cap of the mixing syringe had broken off in the delivery cannula.No twisting or tension beyond normal had been put on the mixing syringe when threading to the delivery cannula.They were unable to get the white tip out as it was lodged in there, unable to expel any additional product.By this time, the original bonesync had hardened and would not have gone through a new delivery device, so both components had to be opened again.
Additional Manufacturer Narrative
Additional information: b4, b5, g3, h6.
Event or Problem Description
Additional information was provided on 6/3/2024 where the sales representative stated that this event occurred during a subchondroplasty of acterabular cyst procedure on (b)(6) 2024.The device did not break inside the patient, the broken part stayed inside the delivery cannula.
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 can be attributed to user error due to excessive pressure used when drawing back the syringe.

• Brand Name: IOBP HIP CLOSED 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: 19622200
• Report Number: 1220246-2024-06443
• Device Sequence Number: 17732367
• Product Code: FMF
• UDI-Device Identifier: 00888867337329
• UDI-Public: 00888867337329
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 12/31/2024
• Device Model Number: IOBP HIP CLOSED TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2010-CT
• Device Lot Number: 10599360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 06/06/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 12/19/2024; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2020
• 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