• 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. SURESHOT META STANDARD DRILL GUIDE PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • 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. SURESHOT META STANDARD DRILL GUIDE PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 71692814
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
It was reported that during surgery and after opening the package the navigation couldn't detect the newly drill guide probe. The distal screws were inserted by free hand which is considered a different technique, there was a delay from 30 to 60 minutes with no impact to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESHOT META STANDARD DRILL GUIDE PROBE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9532667
MDR Text Key177209973
Report Number1020279-2019-04686
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 08/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71692814
Device Catalogue Number71692814
Device Lot Number18JK00029
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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

-
-