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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 Device Inoperable (1663); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/10/2017
Event Type  Injury  
Event Description
It was reported a surgery was delayed by 40 minutes due to the targeter not working.
 
Manufacturer Narrative
(b)(4).
 
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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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia de santis
1450 brooks road
memphis, TN 38116
0416283206
MDR Report Key6422289
MDR Text Key70522093
Report Number1020279-2017-00201
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71692801
Device Lot NumberND1334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2017
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
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age16 YR
Patient Weight25
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