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

Model Number 71514630

Device Problem Break (1069)

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

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that, during tka surgery, profix femoral impactor broke.All fragments were removed from the patient.Procedure was concluded with the same device, without a delay or an injury to the patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports femoral impactor broke while being used outside of the patient.Per email communication, no broken pieces had to be removed from the patient and the procedure was completed using the same device, without a surgical delay or injury to the patient.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A visual inspection confirmed the tip is broken off the profix oxinium fem impactor.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch a review of the risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Case-2020-00025260-1.

• Brand Name: PROFIX OXINIUM FEM 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: 10859820
• MDR Text Key: 216830517
• Report Number: 1020279-2020-06555
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010473486
• UDI-Public: 03596010473486
• Combination Product (y/n): N
• 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: 03/08/2021

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 Expiration Date: 05/06/2013
• Device Model Number: 71514630
• Device Catalogue Number: 71514630
• Device Lot Number: 03DM06347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention