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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 Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Event Description
In the second affiliated hospital of (b)(6) medical university, during the humeral internal nail fixation of closed reduction of humeral shaft fracture surgery, the sureshot showed "targeted invalid or broken tool, please exchange!" and it could not be used. Surgery was completed by free hands to insert the distal screws under x-rays.
 
Manufacturer Narrative
The associated sureshot targeter was returned and evaluated. Visual inspection of the product found a cut 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 trouble shooting suggestions. We consider this investigation closed. Should additional information be received, the complaint will be reopened. Credit will be issued for the device.
 
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Brand NameSURESHOT TARGETER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7807540
MDR Text Key117960738
Report Number1020279-2018-01611
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 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71692801
Device Lot NumberND4100
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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