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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 07/28/2018
Event Type  malfunction  
Event Description
It was reported that the sureshot targeter didn't work.Doctor used free hands to insert the screw.
 
Manufacturer Narrative
The associated sureshot targeter was returned and evaluated.A visual inspection of the device noted some stains on the orange silicon overmold.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.We consider this investigation closed.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 Key8112034
MDR Text Key128728504
Report Number1020279-2018-02626
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 01/10/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue Number71692801
Date Manufacturer Received11/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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