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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 Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the sureshot targeter did not work.The surgeon used c-arm to complete the procedure and there was a delay shorter of 30 minutes.There was no deviation, following the original procedure plan to complete the surgery.The patient was not affected.
 
Manufacturer Narrative
The associated complaint device was not returned.A visual evaluation of the provided picture could not confirm the stated failure mode.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
 
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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 Key8547031
MDR Text Key143035903
Report Number1020279-2019-01653
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 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71692801
Device Lot NumberND4537
Date Manufacturer Received04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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