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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR
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SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR Back to Search Results
Catalog Number 71441144
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A device malfunction was identified that, upon reoccurrence, may necessitate medical intervention and/or result in an extended surgical delay.
 
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Brand Name
GII MIS DCF ALIGN GDE
Type of Device
PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
robert rust
1450 brooks road
memphis, TN 38116
MDR Report Key7377467
MDR Text Key103827725
Report Number1020279-2018-00656
Device Sequence Number1
Product Code MBH
UDI-Device Identifier03596010497161
UDI-Public03596010497161
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71441144
Device Lot Number15BM13762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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