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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.

 
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Brand NameGII MI IN SLT 3 MO TI CU BL LT
Type of DevicePRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL
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
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9639862
MDR Text Key177238251
Report Number1020279-2020-00407
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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