MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,1.9,30,60,MITEK; ARTHROSCOPE

Catalog Number	242095
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during return inspection it was observed that the hd epscp,1.9,30,60,mitek scope was found to be cloudy.There was no patient involvement.No additional information could be 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.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.H10 additional narrative: h4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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.Investigation summary: the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, needle outer tube dent(s) bent/bulged outer tube bent.Outer tube damaged, distal tip damaged.Optical system, optical components broken lenses in optical system.Cosmetic issue scratches/dents.Engraving/identification datamatrix code level a.Broken (2+ pieces) : device fractured, visual : deformed/bent, visual : scratched/nicked, labeling : illegible etch.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated 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.Device evaluation update: upon further evaluation, it was found that additional failures were observed and the investigation has been updated accordingly.Investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: outer tube damaged, needle outer tube dent(s) bent/bulged outer tube bent, outer tube damaged, distal tip damaged, optical system, optical components broken lenses in optical system, cosmetic issue scratches/dents, engraving/identification datamatrix code level a.Broken (2+ pieces) : device fractured, visual: deformed/bent, visual: scratched/nicked, labeling: illegible etch.Per service report, this complaint was confirmed.The optical, housing, tube, label were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Based on the investigation findings, the faulty parts were identified as the root cause for the device failure during the service evaluation.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.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.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• Brand Name: HD EPSCP,1.9,30,60,MITEK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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: 18919048
• Report Number: 1221934-2024-00913
• Device Sequence Number: 17865642
• Product Code: HRX
• UDI-Device Identifier: 10886705031917
• UDI-Public: 10886705031917
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 242095
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 03/28/2024; 01/09/2025
• Initial Report FDA Received Date: 03/16/2024
• Supplement Report FDA Received Date: 03/22/2024; 04/11/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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