MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG DRIVER RETAINING ROD ASSY; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674087

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  Injury  

Event Description

It was reported that during surgery with lag/comp screw kit 95/90 and lag driver retaining rod assy, while inserting a lag screw, the retaining rod came out and the guide pin stuck in acetabular, all three devices were removed from the body, dent was found on the retaining rod; the procedure was successfully completed with minimal delay with a change in technique, no other complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the lag driver retaining rod assy is dented.The device shows significant signs of wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LAG DRIVER RETAINING ROD ASSY
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10549293
• MDR Text Key: 207406373
• Report Number: 1020279-2020-04640
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010580443
• UDI-Public: 03596010580443
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674087
• Device Catalogue Number: 71674087
• Device Lot Number: 10FSP0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CN: 71674067. LN 10FSP0018; CN: 71677095. LN: 20BM12972; CN: 71674067. LN 10FSP0018; CN: 71677095. LN: 20BM12972
• Patient Outcome(s): Required Intervention