MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOPAEDIC RECONSTRUCTION DEV; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number UNKN01000000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported that, during an unspecified surgery, the wrong implant was used on a patient.The problem was addressed by performing a revision surgery.The patient outcome is unknown.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.As device information was not made available, device history record , risk management review and complaint history review cannot be completed.According to clinical/medical investigation, this case reports that a revision was performed due to the wrong implant being used on the patient.Information regarding what type of initial procedure that was performed, as well as the requested x-rays and surgical records have not been provided.Therefore the patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.Should clinically relevant documentation be provided, this clinical/medical task may be re-evaluated.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Per the senior author, none of the complications were implant related and were as the article implied, procedure related.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10606698
• MDR Text Key: 209172876
• Report Number: 1020279-2020-04968
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01000000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention