MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71440190

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that during procedure tka, that the device was broke while impacting the femur.The procedure was completed without a delay and backup from smith&nephew was available to finish the surgery.Any other issue that could affect the patient's condition was not reported by this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Updated b5: description (all broken pieces were recovered).

Event Description

It was reported that during procedure tka, that the device was broke while impacting the femur.All broken pieces were recovered.The procedure was completed without a delay and backup from smith&nephew was available to finish the surgery.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms 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.No broken pieces were returned with the device.This device was manufactured in 2011.This device exhibits signs of significant wear and usage.A medical investigation was conducted and this case reports that during the surgery, the impactor broke during impaction.Per email communication, no pieces fell inside the patient, and all broken pieces were recovered.The procedure was completed with a backup device, and there was no patient injury or delay in the surgery.Since no patient harm is alleged, no further assessment is warranted at this time.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 or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10457039
• MDR Text Key: 204462121
• Report Number: 1020279-2020-04223
• 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: 10/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440190
• Device Catalogue Number: 71440190
• Device Lot Number: 11HM11073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 07/31/2020; 10/22/2020
• Supplement Dates FDA Received: 08/26/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention