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 02/18/2021

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.During a treatment of a pathologic fracture of a tibia, a 6.0mm flexible reamer broke at the distal end, when drilling from proximal to distal in preparation of delivering an illuminoss implant.All pieces of the reamer were removed with ball tipped guidewire.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: the 6mm flexible reamer broke at the distal end of the tibia when drilling from proximal to distal in preparation of delivering our illuminoss catheter.The entry point to the canal reaming pathway was at an angle of trajectory that required bend, as the user navigated the procedure to drill from proximal to distal end of the tibia.The user was able to remove all pieces of the reamer by pulling proximally on the 2mm ball tipped guidewire.The incident did not add significant delay to the procedure, and no harm to patient.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 device was received on april 1, 2021.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.Furthermore, that the observed break pattern is consistent with a grerat deal of torquing force applied rapidly, rather than gradually over time.Engineering evaluation further noted that use of the device under high torque in a position of significant bend could result in the multiple break points observed.Follow-up with the complainant confirmed that the entry point to canal reaming pathway was at an angle of trajectory that required significant bend, as the user navigated the procedure to drill from proximal to distal end of the tibia.No x-rays were provided to the firm to aid in the investigation.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: 16826111
• MDR Text Key: 314122564
• Report Number: 3006845464-2023-00025
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 39 YR
• Patient Sex: Female