MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SHE_2RSTCK_5.9,30,167CW_ MITEK; ACCESSORIES, ARTHROSCOPIC

Catalog Number	242025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during device setup it was observed that the she_2rstck_5.9,30,167cw_ mitek device had a broken scope sheath.This event did not occur during surgery.All available information has been disclosed.
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: (b)(4) the product was not returned to depuy synthes mitek, however photos were provided for review.The photo investigation revealed that the she_2rstck_5.9,30,167cw_ mitek had missing knob at the stopcock assembly.The overall complaint was confirmed as the observed condition of the she_2rstck_5.9,30,167cw_ mitek would contribute to the complained device issue.Based on the investigation findings, a potential cause for the reported condition could be traced to procedural variables, such handling of the device during cleaning and sterilization process.As per the instructions for use; sheath disassembly instructions are provided, and 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.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: d9, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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.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: investigation summary: the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.¿ upon visual inspection revealed that the she_2rstck_5.9,30,167cw_ mitek had the screw from one of the valves broken.Additionally, the devices was found bend at the tip.Rust condition could be observed on the screws.The broken screw was returned for evaluation.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.The overall complaint was confirmed as the observed condition of the she_2rstck_5.9,30,167cw_ mitek would have contributed to the complained issue.¿ based on the investigation findings, the potential cause is traced to end of life.As per the instructions for use, handle the endoscope with care.Hard impacts, contact with abrasive surfaces, particularly to the distal end, may cause damage, and it has been determined that no corrective and/or preventative action is required.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.Device history lot: a manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.

• Brand Name: SHE_2RSTCK_5.9,30,167CW_ MITEK
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 19613960
• Report Number: 1221934-2024-02223
• Device Sequence Number: 6306257
• Product Code: NBH
• UDI-Device Identifier: 10886705029013
• UDI-Public: 10886705029013
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 242025
• Device Lot Number: 1488593
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 08/02/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/26/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown