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

Model Number 71440005

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

It was reported that during a tka the femoral implant impactor broke outside the patient, all pieces recovered; there is no information regarding how the procedure was completed.No other patient injury or complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms one of the green cam arms is missing from the device.The missing piece was not returned.This device was manufactured in 2017.This device shows significant signs of wear/usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality 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.We consider this investigation closed.

Event Description

It was reported that during a tka the femoral implant impactor broke outside the patient, all pieces recovered; the procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.

• Brand Name: FEMORAL IMPLANT 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: 10623795
• MDR Text Key: 209749771
• Report Number: 1020279-2020-05117
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556034156
• UDI-Public: 00885556034156
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440005
• Device Catalogue Number: 71440005
• Device Lot Number: 17BM09708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1