MAUDE Adverse Event Report: ORTHOSENSOR 1855 GRIFFIN ROAD ORTHOSENSOR VERASENSE KNEE SYSTEM; VERASENSE KNEE SYSTEM FOR JOURNEY II BCS

Catalog Number SNN-JRNYBCS78-L

Device Problems Computer Software Problem (1112); Disconnection (1171)

Patient Problem No Information (3190)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

Product was activated then properly transferred to sterile field.Device then disconnected from the receiver, and no longer transmitted data.This was discovered while attempting to zero the device.Although troubleshooting attempts were made, the device was never again able to transmit data, and so was not inserted in the patient.The device was returned to sponsor for reimbursement.

• Brand Name: ORTHOSENSOR VERASENSE KNEE SYSTEM
• Type of Device: VERASENSE KNEE SYSTEM FOR JOURNEY II BCS
• Manufacturer (Section D): ORTHOSENSOR 1855 GRIFFIN ROAD; ste a-310; dania beach FL 33004
• MDR Report Key: 6092304
• MDR Text Key: 59780009
• Report Number: MW5065944
• Device Sequence Number: 1
• Product Code: ONN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: SNN-JRNYBCS78-L
• Device Lot Number: 051315V12704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 113