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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
Model Number 71692801
Device Problems Failure to Read Input Signal (1581); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during surgery, when the targeter was connected to the interface, an error message "the targeter is invalid or broken" was displayed. After several attempts of connect/disconnect, the message kept showing. Procedure was performed using radiolucent, the operation was completed with a non-significant delay. Patient was not injured as consequence of this problem.
 
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Brand NameSURESHOT TARGETER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin
austin, TX 78735
5123913905
MDR Report Key12755816
MDR Text Key284370042
Report Number1020279-2021-07855
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71692801
Device Catalogue Number71692801
Device Lot NumberND5079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
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 Unkown

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