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

Catalog Number CT-0241

Device Problem Material Separation (1562)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.A 4.5mm and a 5.5mm burr broke during use in treatment of an ulna.All device pieces were removed from the patient and the patient outcome was good.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: the user was treating a traumatic ulna fracture in a cancer patient.A small awl was used to create an entry hole for either a 9 or 11mm balloon.Then the 4.5mm burr was used to ream the canal and was broken during use.Then the 5.5mm burr was used to ream the canal and got temporarily stuck in the patient and was broken at the time of extraction.All pieces of both instruments were able to be removed from the patient.The user did not feel the burr guide was necessary for use during this case and did not use it.The user successfully implanted the illuminoss implant in the ulna with great cortical wall contact.The patient outcome was good.Records review: a review of manufacturing records was performed, and found that the devices met specification at the time of manufacture and release.Returned product evaluation: product was received on february 9, 2022.Device decontamination and photo-imaging was performed.The product evaluation performed identified that the break patterns observed are consistent with overtorquing of the device during use.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: 16827652
• MDR Text Key: 314169329
• Report Number: 3006845464-2023-00027
• 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-0241
• Device Lot Number: 350704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White