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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 Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Event Description
It was reported that before surgery the device won't target the monitor.No back-up device was available, delay or injury reported.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.There was no evidence that a patient was involved, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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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 Key9531651
MDR Text Key177207131
Report Number1020279-2019-04648
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,health
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71692801
Device Lot NumberND1106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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