MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 2.7 MM X 75 MM; RIGID ARTHROSCOPE

Model Number	242276
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).E3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.Investigation summary : the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: functional : damaged connector tube.Broken (2+ pieces) : device fractured optical.Outer tube damaged, outer tube bent.Distal tip damaged.Optical system, optical components - broken lenses in optical system, less than 50% of lenses defective per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.The user error 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.
Event or Problem Description
It was reported by the sales rep that during an ankle reconstruction procedure on (b)(6) 2023, it was observed that the c-mount endoscope, mitek lock 30 degree x 2.7 mm x 75 mm device was dropped and cracked.During in-house engineering evaluation, it was determined that the optical part on the device was broken/fractured.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 2.7 MM X 75 MM
• Common Device Name: RIGID ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• 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: 16965348
• Report Number: 1221934-2023-02042
• Device Sequence Number: 20143191
• Product Code: HRX
• UDI-Device Identifier: 10886705032143
• UDI-Public: 10886705032143
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 242276
• Device Catalogue Number: 242276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown