MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDUCER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631124

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

It was reported that during set up for an internal fixation surgery, the reducers were noticed to have rust on them.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.

Manufacturer Narrative

H6: the device, imtended for use in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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: REDUCER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11935451
• MDR Text Key: 254257433
• Report Number: 1020279-2021-04984
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010419606
• UDI-Public: 03596010419606
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631124
• Device Catalogue Number: 71631124
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1