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

Catalog Number CT-0239, CT-0225

Device Problem Material Separation (1562)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.Flexible reamer/burr break at the tip while bending around the pelvis.Surgery was not hindered.The user was able to place the illuminoss implant and complete the surgery.No patient harm.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: during canal preparation for a metastatic pelvis case, a front cutting burr and a flexible reamer broke while bending around the pelvis.The instruments were used with the ball tipped guidewire, and all pieces of the instruments were able to be removed.No other tools were required to prepare the canal and there was no significant time delay.The implant procedure was performed as planned.Records review: product identification information was not made available to the manufacturer.Requests to identify device lot number were unsuccessful.Therefore no review of manufacturing records could be performed for this complaint.Returned product evaluation: the product was not returned to the firm for evaluation, as it was disposed of in the or.Although the product was not returned for evaluation, an image of the tip of a broken instrument was provided.The image shows the burr or reamer broken approximately an inch from the cutting tip along the laser cut pattern.The break appears to be clean along the laser cut pattern.The break pattern experienced in this case is consistent with over-torquing of the device during use.The firm noted that the user reported that the instruments were bent significantly during use, which increases the torque stress on the device, and could result in the reported breaks.Conclusion: existing evidence supports that over-torquing of the device is a 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: 16825401
• MDR Text Key: 314117629
• Report Number: 3006845464-2023-00026
• 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, CT-0225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White