MAUDE Adverse Event Report: DEPUY MITEK LLC US RAD32" 4K/UHD MEDICAL DISPLAY

Catalog Number	242672
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by manager via email that 3 monitors failed.First radiance 32¿ 4k/uhd medical display and radiance ultra 32¿ hd medical display had intermittent power.Second radiance 32¿ 4k/uhd medical display presented image degradation, sharpness and color is not as it once was.No replacements are needed.No surgical involvement.
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: according to the information provided, it was reported that 3 monitors failed.First radiance 32¿ 4k/uhd medical display and radiance ultra 32¿ hd medical display had intermittent power.Second radiance 32¿ 4k/uhd medical display presented image degradation, sharpness and color is not as it once was.These monitors were not used by a customer; only used for development from spine team and they deal with nds directly.These monitors are from a depuy lab then cannot repair them; therefore, the wo was closed by error.The units would be as not for human use.Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined, but lack of maintenance can be the most probable root causes of the failure reported.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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: RAD32" 4K/UHD MEDICAL DISPLAY
• Common Device Name: DISPLAY
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10543513
• Report Number: 1221934-2020-02643
• Device Sequence Number: 304139
• Product Code: KQM
• UDI-Device Identifier: 00851455007812
• UDI-Public: 00851455007812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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 Catalogue Number: 242672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1