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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2018
Event Type  malfunction  
Event Description
It was reported that the sureshot targeter got damaged. There was a delay longer than 30 minutes. Doctor changed the technique of the procedure because the sureshot targeter had a malfunction and the procedure ended free hands.
 
Manufacturer Narrative
The associated sureshot targeter was returned and evaluated. A visual inspection of the device noted there are cuts on the cord. Our investigation has confirmed the stated failure. This failure mode has been previously identified and the device is currently being redesigned to help reduce/eliminate this issue from recurrence. No additional actions are being taken at this time. However, we will continue to monitor for future complaints and investigate further as necessary. When having complications with a sureshot device, we encourage you to refer to user manual for troubleshooting suggestions. We consider this investigation closed. Should additional information be received, the complaint will be reopened.
 
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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 Key8112095
MDR Text Key128728186
Report Number1020279-2018-02627
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 company representative,foreig
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71692801
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
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

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