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

Model Number	242043
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
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 knee arthroscopy procedure on (b)(6) 2020, the arthroscope, 4.0 mm, 30 deg, 175 mm (stryker style) was dropped.Upon inspection, the scope seemed foggy when looking through it.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.H10 additional narrative: investigation summary = > the complaint device was sent to the supplier and evaluated.It was reported that the arthroscope, 4.0mm, 30 deg, 175mm (stryker style) was dropped.Upon inspection, the scope seemed foggy when looking through it.Per service report, this complaint can be confirmed.The following defects were found during evaluation: distal tip was damaged objective was damaged optics were damaged image was cloudy and foggy.The defective parts were replaced, and the device was tested and found to be working according to specifications.The physical damages to the device including damage to distal tip, objective and optics are most likely a result of user mishandling of the device or a possible fall.The physical damage to the scope would have caused the customer to experience foggy lens and poor image quality.A manufacturing record evaluation was performed for the finished device [25122] 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.A manufacturing record evaluation was performed for the finished device [25122] number, and no non-conformances were identified.

• 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: 11178800
• Report Number: 1221934-2021-00124
• Device Sequence Number: 2914612
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 01/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1