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

Catalog Number	242025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
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.Investigation summary: the product was not returned to j&j medtech orthopaedics, however a video was provided for evaluation.Visual inspection of the returned video found that the obturator and the sheath are being hold by the customer, then it was separated and reinserted with some resistance.No other anomalies were noted.The device was manufactured in november 2020 which is more than 4 years old.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 (b)(4) would have contributed to the complained device 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.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 record review: a device history review was performed and no non-conformances were identified related to the reported condition.
Event or Problem Description
It was reported that during an anterior reconstruction of the cruciate ligament procedure, it was discovered that the she_2rstck_5.9,30,167cw_ mitek device was difficult to put on and take off.After the surgery, the operation of the device was evaluated, and it was observed that the inner and outer tubes were quite stiff when the button was pressed to disconnect them from their connected state.There was no visible damage or distortion to the exterior of the device.However, when attempting to attach the inner and outer tubes, there was noticeable resistance during the final 2 mm or so before they clicked into place.According to the hospital staff, the device had started to stiffen recently.The spare device was evaluated, and it worked as expected.It was reported that there were no delays to the surgical procedure as a spare device was available 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.
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: b5: during subsequent follow-up with the customer additional information was obtained.The reporter clarified that the malfunction occurred immediately after the surgery began.The surgeon intended to insert the inner and outer tubes into the rear portal, remove the inner tube, and then insert the camera, but the inner tube would not dislodge.After several attempts, the surgeon finally removed the inner tube and utilized the switching stick instead to proceed with the surgery.Correction: d4: the expiration date has been removed.

• 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: 21412809
• Report Number: 1221934-2025-00598
• Device Sequence Number: 18221852
• Product Code: NBH
• UDI-Device Identifier: 10886705029013
• UDI-Public: (01)10886705029013(10)1617995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/19/2025

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: 1617995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2020
• 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