MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD C-MNT SCP,2.7,30,75,MITEK; ARTHROSCOPE

Catalog Number 242276

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

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: e3: reporter is a j&j sales representative.D10.Concomitant med products and therapy dates: obturator device, sheath device ( on (b)(6) 2024).H4: the device manufacture date is unknown.(b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported that prior to an unspecified surgical procedure it was observed that the picture of the hd c-mnt scp,2.7,30,75,mitek scope was fuzzy, and the obt_button_2.7,75_mitek device was bent and the she_2rstck_3.8,univ,75_mitek sheath was bent.This event did not occur during surgery.There was no patient involvement.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for the same event in (b)(4).

• Brand Name: HD C-MNT SCP,2.7,30,75,MITEK
• Type of Device: 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: 18968007
• MDR Text Key: 339322473
• Report Number: 1221934-2024-00960
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705032143
• UDI-Public: 10886705032143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1