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

Model Number	IOBP KNEE CLOSED TIP PROCEDURE KIT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a clindex notification indicated that a severe complication occurred to a patient listed on the shoulder arthroplasty registry.This event was initially indicated as probably related to the intraosseous bioplasty procedure on (b)(6) 2022.During the procedure, the increased torque on the drill caused a 3cm by 0.5cm wafter femoral condyle fracture laterally.An abs-2000-ct intraosseous bioplasty core decompression delivery kit was used as an abs-2010-05 allosync pure and a abs-10062t angel cprp system with aspiration kit.Additional information received on (b)(6)2023: this occurred during an lobp femoral condyle.The fracture was not repaired, and the patient was monitored.No further information was provided.
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.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 force applied during insertion on the drill.

• Brand Name: IOBP KNEE 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: vik bajnath ; 8009337001
• MDR Report Key: 16761947
• Report Number: 1220246-2023-06550
• Device Sequence Number: 11493061
• Product Code: FMF
• UDI-Device Identifier: 00888867337312
• UDI-Public: 00888867337312
• 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: Study,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 CLOSED TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2000-CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown