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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT TARGETER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. SURESHOT TARGETER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 71692801
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the sureshot targeter did not work. The surgeon used c-arm to complete the procedure and there was a delay shorter of 30 minutes. There was no deviation, following the original procedure plan to complete the surgery. The patient was not affected.
 
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Brand NameSURESHOT TARGETER
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 Key8547031
MDR Text Key143035903
Report Number1020279-2019-01653
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71692801
Device Lot NumberND4537
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? No
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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