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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII QUICK CONNECT HANDLE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. GII QUICK CONNECT HANDLE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71440044
Device Problems Component Missing (2306); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
It was reported that, during inspection or set up before a tka surgery, it was found that the gii quick connect handle did not connect properly to a baseplate trial as one of the metal ball bearings were missing from the tip of the handle.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.
 
Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device has few nicks and scratches.The device shows signs of extensive use.A functional evaluation confirmed the stated failure mode.The device quick connect to another mating part mechanism is not able to function as intended, rendering device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
GII QUICK CONNECT HANDLE
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 Key11849621
MDR Text Key251441978
Report Number1020279-2021-04457
Device Sequence Number1
Product Code HRY
UDI-Device Identifier03596010213860
UDI-Public03596010213860
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/13/2012
Device Model Number71440044
Device Catalogue Number71440044
Device Lot Number02HM01635
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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