MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692802

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the touch of the monitor does not work, no delay was reported.No backup available.

Manufacturer Narrative

After reviewing the historical data there's no evidence that a previous serious injury has occurred due to this kind of failure mode, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: TRAUMA INTERFACE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8209206
• MDR Text Key: 131829112
• Report Number: 1020279-2019-00007
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K043536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Device Lot Number: ACA8004129
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1