MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR; PROSTHESISHIPFEMORALCOMPONENTCEMENTEDMETAL

Model Number 71440190

Device Problem Break (1069)

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

Event Date 12/02/2019

Event Type  malfunction  

Event Description

It was reported that during a thr procedure, device broke while impacting.No delay.Backup device available.No impact or injury to patient reported.

Manufacturer Narrative

The associated complaint device was returned and evaluated.The as-received impactor showed a fracture at the acetal center alignment nodule that comes into contact with the femoral component.This fracture appears to have been caused by an impact overload mechanism.The fracture of the impactor was likely due to the impact forces applied to the instrument during seating of the femoral component.No destructive analysis was performed.It is unknown if the fracture initiated in a previous surgery.This device was manufactured in 2012.This device exhibits signs of significant wear and usage.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.If new information is received in the future, this complaint can be re-opened.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.The as-received impactor confirmed a fracture at the acetal center alignment nodule that comes into contact with the femoral component.This fracture appears to have been caused by an impact overload mechanism.The fracture of the impactor was likely due to the impact forces applied to the instrument during seating of the femoral component.It is unknown if the fracture initiated in a previous surgery.This device was manufactured in 2012.This device exhibits signs of significant wear and usage.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESISHIPFEMORALCOMPONENTCEMENTEDMETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9533788
• MDR Text Key: 177211394
• Report Number: 1020279-2019-04707
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214379
• UDI-Public: 03596010214379
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: 12GM07668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1