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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL

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SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL Back to Search Results
Model Number 71440391
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 08/31/2020
Event Type  Malfunction  
Event Description

It was reported that during inspection, patella resection guide was noticed to have a screw missing.

 
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Brand NamePATELLA RESECTION GUIDE
Type of DevicePRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
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
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10591565
MDR Text Key208711500
Report Number1020279-2020-04902
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 10/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71440391
Device Catalogue Number71440391
Device LOT Number16FSP0022
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 Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2016
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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