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

Model Number IOBP KNEE CLOSED TIP PROCEDURE KIT

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/09/2022

Event Type  Injury  

Event 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.

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.

• Brand Name: IOBP KNEE CLOSED TIP PROCEDURE KIT
• Type of Device: 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
• MDR Text Key: 313506897
• Report Number: 1220246-2023-06550
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867337312
• UDI-Public: 00888867337312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IOBP KNEE CLOSED TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2000-CT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other