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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from china that during an arthroscopy procedure, it was discovered that the fuslitegu_olym-acmi_3.5mmx3.0m device had a superficial rupture.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: investigation summary: 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 appeared to have the insulation at the proximal end of the cord slightly detached, however the reported condition could not be clearly observed and no observations pertaining to the nature of the reported event could be identified.The overall complaint was confirmed as the observed condition of fuslitegu_olym-acmi_3.5mmx3.0m would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.Multiple factors are associated with this type of failure, the complaint device needs to be physically evaluated 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 mitek 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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection and functional testing of the returned device.Visual inspection revealed that fuslitegu_olym-acmi_3.5mmx3.0m showed wear mark, these wear marks as usual on these types of reusable devices, the insulation was loose at the proximal end of the cord.Rust was seen at the external end of the female connector.A functional test was performed for the device, the female end tip was directed to a light source, the light emission of the device was poor.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the fuslitegu_olym-acmi_5.0mmx3.0m would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of j&j medtech orthopaedics 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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 20136445
• Report Number: 1221934-2024-03051
• Device Sequence Number: 17991587
• Product Code: FCW
• UDI-Device Identifier: 10886705028818
• UDI-Public: (01)10886705028818(10)WO184237
• 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,Followup,Followup
• Report Date (Section B): 09/04/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 09/25/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/24/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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