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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 04/27/2017
Event Type  malfunction  
Event Description
It was reported that during surgical fixation of distal femur, the sureshot devices does not guide the drill accurately to the distal hole of the implant as it appear on the screen. The surgeon change to old method of using x ray to locate the distal hole of the nail.
 
Manufacturer Narrative
The associated complaint device was returned and evaluated. A visual examination of the returned sureshot targeter indicated no obvious signs of damage. A functional evaluation of the targeter indicated that the targeting was accurate. One of the other components may have potentially been the cause. We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
 
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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
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key7323397
MDR Text Key101969201
Report Number1020279-2018-00285
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71692801
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
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

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