• 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. EVOS 2.7/3.5MM PL-D HUM PL 17H R 206MM PLATE, FIXATION, BONE

  • 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. EVOS 2.7/3.5MM PL-D HUM PL 17H R 206MM PLATE, FIXATION, BONE Back to Search Results
Model Number 72466217
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2020
Event Type  Injury  
Event Description
It was reported that during procedure and inside the patient the two evos posterolateral distal humerus screws holes failed to engage with the locking screws. S+n backup device available. Surgery was delayed for no more than 30 min.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVOS 2.7/3.5MM PL-D HUM PL 17H R 206MM
Type of DevicePLATE, FIXATION, BONE
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 Key10480550
MDR Text Key205245204
Report Number1020279-2020-04364
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K173293
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
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number72466217
Device Catalogue Number72466217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2020 Patient Sequence Number: 1
-
-