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

Catalog Number CT-0242

Device Problem Material Separation (1562)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by the user: during the treatment of a traumatic fibula fracture in germany, the doctor reported that the 6.5mm burr broke.Prior to that, the user reported that they had difficulty getting the burr into the bone canal.All pieces of the device were removed.The planned procedure was successfully completed without significant delay.The patient outcome was good.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 decontaminated device was received on february 25, 2022.Device 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.

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.A 6.5mm bur broken during a fibula case in germany.All instrument pieces were removed from the patient.The patient outcome was good.No harm to patient.

• 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: 16829979
• MDR Text Key: 314168339
• Report Number: 3006845464-2023-00028
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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-0242
• Device Lot Number: 350709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White