MAUDE Adverse Event Report: DEPUY MITEK LLC US IMGMGMNT_WRLESSTX/RX, DVI&SDI; UNKNOWN COMMON DEVICE NAME

Catalog Number 242356

Device Problem Poor Quality Image (1408)

Patient Problem Not Applicable (3189)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable without a lot number the device history records review could not be completed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary the device was sent to the supplier for evaluation.The repair report indicates: testing confirmed the poor image quality.Software reloaded and the device functions properly.A software issue is the root cause of this reported failure.This complaint can be confirmed.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

This is report 2 of 2 for the same event.It was reported by the sales rep that during a shoulder repair procedure two wireless videos had poor image quality.The sales rep stated that the secondary unit was turned off then back on and the units did not sync together and had to paired again.The sales rep stated that the image had poor quality and then corrected itself.The case was completed with a three minute delay to turn the devices off then on and then repair.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: IMGMGMNT_WRLESSTX/RX, DVI&SDI
• Type of Device: UNKNOWN COMMON DEVICE NAME
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 9125103
• MDR Text Key: 203981768
• Report Number: 1221934-2019-58602
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2019
• Date Manufacturer Received: 01/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1