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

Model Number 71360020

Device Problem Separation Failure (2547)

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

Event Date 07/20/2020

Event Type  malfunction  

Event Description

It was reported that during a thr procedure the accord tensioner locking mechanism was found stuck in locked position.No injuries or surgical delays reported.An s+n back up device available.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection does not confirm any obvious signs of damage.This device was manufactured in 2016.This device exhibits signs of moderate wear and usage.A functional evaluation was conducted and confirms the locking mechanism is seized in place causing the stated failure.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.This device is a 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.We consider this investigation closed.

• Brand Name: ACCORD TENSIONER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10408099
• MDR Text Key: 202945102
• Report Number: 1020279-2020-03923
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010485359
• UDI-Public: 03596010485359
• 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: 08/18/2020

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: 71360020
• Device Catalogue Number: 71360020
• Device Lot Number: 16GM11089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1