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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 Problems Computer Operating System Problem (2898); Appropriate Term/Code Not Available (3191)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/23/2018
Event Type  Injury  
Event Description
It was reported that during surgery the sureshot targeter was not functioning as designed and it was unfit for use. Surgeon had to freehand distal locking to complete the surgery.
 
Manufacturer Narrative
The associated sureshot targeter was returned and evaluated.  visual inspection of the product found the cord is sliced in one location. A functional evaluation 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.  a clinical evaluation noted that no patient harm or injury occurred as a result of the device related incident. The procedure was completed without surgical delay using freehand distal locking. No further investigation is warranted for this complaint; 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 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
MDR Report Key7631921
MDR Text Key112132064
Report Number1020279-2018-01180
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71692801
Device Lot NumberND1988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/22/2018 Patient Sequence Number: 1
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