MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM; CABLES

Catalog Number	001388LX9
Medical Device Problem Codes	Material Fragmentation (1261); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a spinal fusion procedure, the glass shattered on the ul pro fused headlight cable 9ft (001388lx9) connection to the mlx light source."it was very hot and charred the surgeon's surgical gown." it was reported that the device was not in contact with the patient and no injury or surgical delay occurred.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), d9, g3, g6, h2, h3, h6, h11 the ul pro fused headlight cable 9ft, 275cm (001388lx9) was not returned for evaluation after three good faith effort (gfe) attempts were made.Therefore, a definite root cause of the reported issue could not be determined.Based on the reported complaint, the probable root cause for this ul pro fused headlight cable having shattered glass on the cable is rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Common Device Name: CABLES
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20649471
• Report Number: 3006697299-2024-00162
• Device Sequence Number: 8996323
• Product Code: FST
• UDI-Device Identifier: 10381780168034
• UDI-Public: 10381780168034
• Combination Product (Y/N): N
• PMA/510(K) Number: K864380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 001388LX9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/10/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown