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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71434332
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2020
Event Type  malfunction  
Event Description
It was reported that during a tka procedure the legion tibial cutting block right trocar pins cold-welded into tibia cutting block and unable to remove during surgery.Surgery was finished with the same device.Surgery was not delayed.The patient was not harmed.
 
Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.A visual inspection confirmed the the pin is stuck in cutting block.The devices show significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 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
LGN TIBIAL CUTTING BLOCK RIGHT
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 Key10436642
MDR Text Key203837072
Report Number1020279-2020-04120
Device Sequence Number1
Product Code HRY
UDI-Device Identifier03596010549822
UDI-Public03596010549822
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/18/2020
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 Number71434332
Device Catalogue Number71434332
Device Lot Number17KM07791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received08/21/2020
Supplement Dates Manufacturer Received09/10/2020
Supplement Dates FDA Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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