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

Catalog Number CT-0225

Device Problem Material Separation (1562)

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

Event Date 02/12/2021

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During a procedure to treat metastatic distal humerus fracture, supplemented with a plate, a 6.0mm reamer broke during surgery.All pieces of the device were removed from the patient.There was no impact on the patient.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: the user was performing fixation for a metastatic distal humerus fracture, with illuminoss implant and plate.The procedure involved removing a tumor as well.The entry point for the procedure was retrograde.The surgeon mentioned that they needed to exert additional force on the reamer when operating it within the bone canal.The reamer broke fairly soon after the user began using it.All the pieces of the broken reamer were removed with use of the ball-tipped guidewire.There was no impact on the patient.Records review: a review of manufacturing records was performed, and found that the device met specification at the time of manufacture and release.Returned product evaluation: the firm was not able to perform product evaluation on the device, as it was disposed of at the hospital.Although the product was not returned for evaluation, pictures of the device were provided.These images show a clean break pattern.Conclusion: existing evidence supports that over-torquing of the device is a possible cause of this event, although this cannot be definitely proven with the evidence available to the firm at this time.

• 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: 16824790
• MDR Text Key: 314107110
• Report Number: 3006845464-2023-00023
• 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: Distributor
• 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 Catalogue Number: CT-0225
• Device Lot Number: 400230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White