MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY ANTERIOR BROACH HDLE KIT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71365601

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that, during procedure, there was an issue with the implant sitting high after broaching.Procedure was concluded with the same devices, without a delay or and injury reported.

Manufacturer Narrative

The devices, used in treatment, were returned for evaluation.A visual inspection confirms all the broaches are dull.These devices were manufactured in 2006, 2013 and 2014.These devices exhibit signs of significant wear and use.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 a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instruments 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.

• Brand Name: ANTHOLOGY ANTERIOR BROACH HDLE KIT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10499571
• MDR Text Key: 205873781
• Report Number: 1020279-2020-04420
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010559968
• UDI-Public: 03596010559968
• 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
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71365601
• Device Catalogue Number: 71365230KT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1