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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 No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2018
Event Type  malfunction  
Event Description
During surgery, the disk was connected to the monitor, which showed no image, then c-arm to lock.Delay:0-30m, no injury, surgery was completed free hands to insert the screws under c-arm.
 
Manufacturer Narrative
The associated sureshot targeter was returned and evaluated.A visual inspection of the device noted no obvious damage.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 trouble shooting suggestions.Should additional information be received, the complaint will be reopened.
 
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Brand Name
SURESHOT TARGETER
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8176176
MDR Text Key130792159
Report Number1020279-2018-02826
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,user f
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71692801
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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