MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDULLARY FIXATION ROD

Catalog Number CT-0225

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2020

Event Type  malfunction  

Manufacturer Narrative

The 6.0mm reamers are robust instruments that are powered by a medical grade type drill unit which can generate sufficient torque to allow the reamer to trim bone material.If the user encounters significant resistance during the reaming process, this can sometimes overtorque the reamer and cause it to break.It is believed that this may have been the cause of this event.Because the reamer material is radiopaque, the portion that broke free of the reamer could be seen under flouro and was removed with tonsil forceps without delaying the procedure.

Event Description

On (b)(6) 2020, during an implant case involving both proximal humerus, as well as a distal humerus implant, the 6.0 reamer, ct-0225, broke in two places during the reaming process of the distal implant.The approach was standard for a distal humerus case through the lateral condyle using both the solid starting awl followed by the 8mm curved cannulated awl.There was a bit of a cortical bone lip just distal to the tumor section in the distal 1/3 of the humerus that caused initial resistance with the guidewire, and was a point of resistance for our stiffer reamers.Following the two separate breaks of the reamer, a fragment remained in the patient that needed to be removed with a pair of tonsils without challenge.Through a combination of use of various reamers from both the humerus and delivery set, it was noted that our stiffer reamers kept hanging up on cortical bone lip.The same was not the case for our more flexible reamers.After reaming to 8.0mm the rest of the case was unremarkable, and the patient was implanted with a 17x180mm implant distally, and a 22/13x160 implant proximally.Not patient complications resulted from the broken reamer.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC.; 993 waterman avenue; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL INC; 993 waterman avenue; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman avenue; east providence, RI 02914 ; 4017140008
• MDR Report Key: 9667580
• MDR Text Key: 221302097
• Report Number: 3006845464-2020-00002
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: CT-0225
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR