MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4K C-MNT SCP,4.0,30,167,MITEK; ARTHROSCOPE

Catalog Number 242268

Device Problems Break (1069); Mechanical Problem (1384); Device-Device Incompatibility (2919); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/03/2024

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: camera head ac - c-mount device, on (b)(6) 2024 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, distal tip distal tip damaged, illumination distal tip fiber damaged, optical system, optical components broken lenses in optical system, cosmetic issue rust/discoloration, engraving/identification datamatrix code level a, coupler coupler damaged, broken (2+ pieces) : device fractured, functional : damaged connector, visual : corrosion/rusting/pitting, functional : damaged connector per service reports, this complaint cannot 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.(b)(4).

Event Description

It was reported by the sales rep that after an anterior cruciate ligament procedure, it was discovered that the staff was taking the endoscope, mitek lock 30 degree x 4 mm x 167 mm device and camera head ac - c-mount apart to put back in the tray to be sent down to sterile processing.The scope became stuck to the camera head with no way to remove until a section of the scope itself became detached leaving the threaded part connected to the camera head.During in-house engineering evaluation, it was determined that the device was fractured.The event was not related to surgery.It was reported that there was no surgical delay.There was no 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.

• Brand Name: 4K C-MNT SCP,4.0,30,167,MITEK
• Type of Device: ARTHROSCOPE
• 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: 19055308
• MDR Text Key: 339986455
• Report Number: 1221934-2024-01100
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705032075
• UDI-Public: 10886705032075
• 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
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 242268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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