• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC P/S CAM MODULE SZ 5 PRSTHSSKNEEPATLL/FEMOROTIBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COATED,PLYMR/MTL/PLYMR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. GII SPC P/S CAM MODULE SZ 5 PRSTHSSKNEEPATLL/FEMOROTIBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COATED,PLYMR/MTL/PLYMR Back to Search Results
Model Number 71433365
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2020
Event Type  Malfunction  
Event Description

It was reported that the hinge attachment on the gii spc p/s cam module sz 5 was found broken off. No case involved.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGII SPC P/S CAM MODULE SZ 5
Type of DevicePRSTHSSKNEEPATLL/FEMOROTIBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COATED,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 Key10492138
MDR Text Key205621654
Report Number1020279-2020-04385
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
Type of Report Initial
Report Date 09/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71433365
Device Catalogue Number71433365
Device LOT Number12AM03189A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-