MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FUSLITEGU_OLYM-ACMI_3.5MMX3.0M; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	242386
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified spinal procedure the fuslitegu_olym-acmi_3.5mmx3.0m device had a light transmittance issue.It was reported that during the operation, noted the light transmission of the fiber was poor.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: udi: (b)(4).Investigation summary: according to the information provided, it was reported that during the operation, noted the light transmission of the fiber was poor.No additional information could be provided.The product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that fuslitegu_olym-acmi_3.5mmx3.0m had foreign matter at the connectors.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the fuslitegu_olym-acmi_3.5mmx3.0m would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be stablished.Multiple factors are associated with this type of failure, the complaint device needs to be physically evaluated in order to determine why the customer experienced the failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device and no non-conformances were identified.

• Brand Name: FUSLITEGU_OLYM-ACMI_3.5MMX3.0M
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19444759
• Report Number: 1221934-2024-01865
• Device Sequence Number: 17918834
• Product Code: FCW
• UDI-Device Identifier: 10886705028818
• UDI-Public: 10886705028818
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2024

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: 242386
• Device Lot Number: WO184237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown