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

Catalog Number CT-0239

Device Problem Material Separation (1562)

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

Event Date 02/02/2021

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During a procedure to treat left, metastatic proximal radius fracture, a 4.5 mm burr broken in surgery.All pieces were removed.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 a fixation procedure for a left, metastatic proximal radius fracture.The surgeon was supported by a resident.The entry point for the procedure was antegrade.There were no difficult angles presented by the anatomy being treated.The surgeon mentioned an error on the part of the resident performing the cleaning of the canal with the burr, that they exerted additional force when operating it within the bone canal.The burr broke fairly soon after the user began using it.All the pieces of the broken burr were removed with the use of the ball-tipped guidewire.There was no patient impact.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: the firm was not able to perform product evaluation on the device, as it was disposed of at the hospital.A picture of the device was provided, however the image didn't allow the firm to make any conclusions about the nature of the break, or its potential cause.The user in this case noted that it was an error on the part of their resident who was using the burr when it broke, that they exerted additional force when operating the drill within the bone canal.Conclusion: existing evidence supports that over-torquing of the device is the probable 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: 16825198
• MDR Text Key: 314111451
• Report Number: 3006845464-2023-00024
• 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-0239
• Device Lot Number: 400769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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: 19 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White