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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR

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SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR Back to Search Results
Model Number 71440145
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2020
Event Type  Malfunction  
Event Description

It was reported that the device was found wear and tear. No injury reported. No case involved.

 
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Brand NameGII P/S CONS HOUSING REAM DOME
Type of DevicePRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, 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 Key10194048
MDR Text Key196427599
Report Number1020279-2020-02727
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,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71440145
Device Catalogue Number71440145
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
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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