MAUDE Adverse Event Report: ARTHREX, INC. FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0'); LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/22/2022, it was reported by a sales representative via (b)(4) that a ar-3240-5027 fused light cable is overhitting.This occurred during an unknown case, with no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Per supplier evaluation a visual inspection found multiple broken fibers and the distal cable end lens are cracked.The condition of the cable consistent with questionable user handling.

• Brand Name: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19309898
• Report Number: 1220246-2024-03230
• Device Sequence Number: 3102069
• Product Code: FST
• UDI-Device Identifier: 00888867029408
• UDI-Public: 00888867029408
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K901035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Model Number: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Device Catalogue Number: AR-3240-5027
• Device Lot Number: WO156351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown