MAUDE Adverse Event Report: DEPUY MITEK LLC US RAD32" 4K/UHD MEDICAL DISPLAY; RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY

Catalog Number	242672
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not function.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: unit would not power on.There was some corrosion on a connector connecting to a internal power board.The device was however deemed non-repairable and was scrapped as per the instructions, hence is unavailable for further evaluation.The faulty parts was identified as the root cause for the device failure during the service evaluation.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.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 lot: 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 that the rad32" 4k/uhd medical display did not function properly.During an in-house engineering evaluation, it was determined that the unit would not power on and there was some corrosion on a connector connecting to an internal power board.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the procedure or whether a like device was available for use.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: RAD32" 4K/UHD MEDICAL DISPLAY
• Common Device Name: RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12370547
• Report Number: 1221934-2021-02561
• Device Sequence Number: 16445657
• Product Code: KQM
• UDI-Device Identifier: 00851455007812
• UDI-Public: 00851455007812
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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 Catalogue Number: 242672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1