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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLASSIC PLATTE 4-LOCH 135 AO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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SMITH & NEPHEW, INC. CLASSIC PLATTE 4-LOCH 135 AO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 71970533
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, the plate would not fit over the lag screw.The lag screw was removed and the surgeon still had difficulty getting the plate to fit over the screw.The screw was once again inserted and eventually forced over lag screw.There was a delay over 30 minutes due to this issue.No patient injuries reported.
 
Manufacturer Narrative
It was reported that during surgery, the plate would not fit over the lag screw.The lag screw was removed and the surgeon still had difficulty getting the plate to fit over the screw.The screw was once again inserted and eventually forced over lag screw.The affected classic platte, used in treatment, was not returned for evaluation as it remained implanted.After repeated requests, smith and nephew has been unable to obtain the device information.As device details were not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.It was communicated that the patient is doing well.Based on this investigation, the need for corrective action is not indicated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential causes could include but is not limited to user/procedural variance, improper size of device used or unclear user instructions.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
CLASSIC PLATTE 4-LOCH 135 AO
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9474119
MDR Text Key170906563
Report Number1020279-2019-04406
Device Sequence Number1
Product Code KTT
UDI-Device Identifier03596010415301
UDI-Public03596010415301
Combination Product (y/n)N
PMA/PMN Number
K993289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71970533
Device Catalogue Number71970533
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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