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

Catalog Number SL-2213260

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: the user reported that the yellow hub was not securely connected to the light fiber or the strain relief, but that the strain relief and depth stop were securely connected to the light fiber.The user reported also that the blue cap was unscrewed from the y-connector.The user reported there was no unusual or rough handling of the light fiber during device prep and placement, and there were no clamps or instruments used on the light fiber.This user had previous experience with the illuminoss implant.The firm concluded that there is no indication the light fiber was used or handled in a way that is not in accordance with the instructions for use.Dhr review: the manufacturing records of the device were reviewed, focusing on the components and materials related to the complaint (the light fiber, the yellow hub, the blue screw cap, and the adhesive used to bond) as well as the manufacturing process of the assembly, gluing, and inspection of these components.The device was in specification at the time of manufacture and release.Returned product evaluation: the product was not able to be returned as it was implanted, and the delivery catheter portion disposed of.While the specific device was not able to be returned, units from this lot were on hand in finished goods inventory.These units were inspected, and all units had the yellow hub securely fastened.2 units were removed from inventory for additional evaluation through a hub-strain relief strip test.These two units passed, demonstrating tensile strength of the hub-strain-relief bond well in excess of the design specification requirement for this bond strength.The reported failure mode could not be replicated with other units in the same lot as the complaint device.Validation review: this review identified that the device manufacturing process is validated, and that the adhesive has been validated to meet the bond strength requirement specification of this device bonded joint.Conclusion: existing evidence supports that the reported malfunction was not caused by user error, or a device design insufficiency.Although the other units in this lot were found to have sufficient bonded joint at the yellow hub, and there have been no other instances of reports of this failure mode, this event may have been caused by an insufficient bond between the 2 components.The specific cause of the insufficient bond between these 2 components for this device was not able to be determined with the available information.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.In a clinic in (b)(6), an illuminoss implant [size 22/13x260mm] was prepared for a case.It was placed in the bone, and infused with monomer.The user then picked up the other end of the implant's light fiber, in order to connect it to the light box in advance of starting the curing cycle, and found that the yellow hub component of the light fiber was not securely connected to the light fiber.Tape was used to secure the yellow hub to the light fiber.The user also noticed the blue cap was unscrewed from the y-connector of the delivery catheter, and attached it.The implant was cured, and after curing the user placed two screws through the implant for rotational stability.There was no indication the implant had not "hardened" when screwing the screws through the implant.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 16827103
• MDR Text Key: 314130284
• Report Number: 3006845464-2023-00017
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: SL-2213260
• Device Lot Number: 410224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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 Sex: Male