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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR

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SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR Back to Search Results
Catalog Number 71441147
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 07/09/2020
Event Type  Malfunction  
Event Description

It was reported that during instrument inspection was found that the pin is stuck in the hole of the genesis ii mis dcf distal cutting block. There was no case involved.

 
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Brand NameGII MIS DCF DISTAL CUT BLK
Type of DevicePRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key10363615
MDR Text Key201589293
Report Number1020279-2020-03693
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
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71441147
Device LOT Number13GM16541
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
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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