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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL LT; PRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL
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SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL LT; PRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL Back to Search Results
Model Number 71441136
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, when the cut block was tightened into the tibial guide, the set screw broke leaving the cut block affixed to the guide and not removable until after the case with a punch and a mallet.There was no delay to the case.Replacement required.
 
Event Description
It was reported that during surgery, when the cut block was tightened into the tibial guide, the set screw broke leaving the cut block affixed to the guide and not removable until after the case with a punch and a mallet.There was no delay to the case.The broken part was outside of the patient incision, it didn't represent a potential harm to the patient.The surgery was not affected as the tibial guide could still be used during the case just fine.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states after reviewing the complaint and the results of investigation it was determined that this device breakage doesn't represent a potential impact to the patient, as the broken part it's outside of the patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
GII MI IN SLT 3 MO TI CU BL LT
Type of Device
PRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9639862
MDR Text Key177238251
Report Number1020279-2020-00407
Device Sequence Number1
Product Code MBH
UDI-Device Identifier03596010484086
UDI-Public03596010484086
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 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71441136
Device Catalogue Number71441136
Device Lot Number06JM01547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Date Manufacturer Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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