MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ARTHSCO,4/140_30_QIK/STRKR HUB; RIGID ENDOSCOPE

Model Number	242043
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that preoperatively to a shoulder repair procedure on (b)(6) 2021, it was observed that the arthsco,4/140_30_qik/strkr hub scope device had dark spots which did not allow to see clearly.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
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.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that ¿the scope has dark spots and doesn't allow to see clearly¿.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: damage to the distal tip, optics damaged and image was dark.Tube bent and dented.Minor scratches on the unit.The objective window, rod lens, tubes and fiber optics were replaced, and laser weld eyepiece as originally designed to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.A manufacturing record evaluation was performed for the finished device [24459] number, and no non-conformances were identified.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.

• Brand Name: ARTHSCO,4/140_30_QIK/STRKR HUB
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12145453
• Report Number: 1221934-2021-02143
• Device Sequence Number: 4199010
• Product Code: HRX
• UDI-Device Identifier: 10886705026234
• UDI-Public: 10886705026234
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 242043
• Device Catalogue Number: 242043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1