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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 Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2019
Event Type  malfunction  
Event Description
It was reported that during use, it was found that navigation is not accurate, the disc has a large error after calibration. Delay of less than 30 minutes. Procedure was concluded with the same device but screws were inserted free hand.
 
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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 Key9008378
MDR Text Key158171379
Report Number1020279-2019-03332
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 12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71692801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
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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