MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DCF VARIABLE SZ GUIDE LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440007

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

It was reported that during set up for a tka, both genesis ii dcf variable size guide left and right were noticed to be loose and not working properly.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.

Manufacturer Narrative

H6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 DCF VARIABLE SZ GUIDE LT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11902197
• MDR Text Key: 253207590
• Report Number: 1020279-2021-04763
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010610386
• UDI-Public: 03596010610386
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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: 71440007
• Device Catalogue Number: 71440007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1