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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. GII DCF VARIABLE SZ GUIDE LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71440007
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
It was reported that during a tka, it was noticed that a gii dcf variable sz guide rt ((b)(4)) and a gii dcf variable sz guide lt ((b)(4)) were loose and not working properly.There was no significant delay and the procedure was finished using smith & nephew back ups.Patient was not harmed.
 
Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.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.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
 
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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 Key11936690
MDR Text Key254253315
Report Number1020279-2021-04999
Device Sequence Number1
Product Code HRY
UDI-Device Identifier03596010610386
UDI-Public03596010610386
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71440007
Device Catalogue Number71440007
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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