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

Catalog Number 71692802

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2020

Event Type  Injury  

Event Description

It was reported that during set up or inspection monitor does not work properly.Procedure was completed with a different technique.No patient harm or delay was reported.

Manufacturer Narrative

Results of investigation: it was reported that during set up or inspection monitor does not work properly.Procedure was completed with a different technique.No delay reported.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes could include but are not limited to hardware failure or electrical interference.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TRAUMA INTERFACE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10359984
• MDR Text Key: 201494977
• Report Number: 1020279-2020-03667
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170280
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention