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

Catalog Number SL-1700280

Device Problem Material Separation (1562)

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

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: to prepare the canal for the introduction of the illuminoss sheath within the humerus, several attempts were made using the illuminoss 6.5mm burrs as well as using a synthese tens nail to clear the canal prior to inserting the sheath/dilator for the implant.Several attempts were made to insert the sheath/dilator into the canal, which was challenging.With manipulation, both the sheath/dilator and the illuminoss implant was inserted into the canal.The curing cycle was initiated and proceeded as expected.After the curing cycle was completed the surgeon removed the light fiber and noted that a portion of the fiber remained in the implant.The surgeon was able to remove the remainder of the fiber.The user determined that the implant was not fully cured after assessing the stability of the fracture with manipulation of the arm of the patient.Another device was opened and its light fiber removed.The light fiber was placed into the catheter still connected to the placed implant, and a second curing cycle was performed.After the second curing session completed, the surgeon believed that the monomer was completely cured based on assessment of the stability of the fracture during manipulation of the arm.Records review: a review of manufacturing records was performed, and found that the device met spefication at the time of manufacture and release.Returned product evaluation: although the product was not returned for evaluation, pictures of the device wer provided.These images show a bright light emanating from what appears to be the break in the fiber below the y-connector.Because the user reported having to perform manipulation to achieve a challenging insertion of the device, the firm performed confirmatory tests to replicate the experienced failure mode with this cause.The firm conducted testing on a similar device from a different lot, and was able to replicate the observed failure mode through excessive and deliberate bending in the area below the y-connector.Conclusion: existing evidence supports that the cause of the break of the light fiber was overly aggressive user manipulation during the insertion of the implant into the sheath, although this cannot be definitely proven with the evidence available to the firm at this time.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During a procedure in (b)(6) 2019 to treat a humerus shaft fracture in germany, after completing the curing cycle for the illuminoss implant, on removal of the light fiber from the implant the user found that the light fiber had broken at the proximal end of the implant.The user believed the monomer had not fully cured in the balloon.The user inserted a light fiber from another device into the balloon and activated a second curing cycle.The user verified that the implant had cured, and the procedure was completed without harm to patient.

• 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: 16826032
• MDR Text Key: 314120584
• Report Number: 3006845464-2023-00018
• 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: 04/27/2023

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: 04/30/2021
• Device Catalogue Number: SL-1700280
• Device Lot Number: 380676
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 60 KG