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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. TRAUMA INTERFACE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 71692802
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem Injury (2348)
Event Date 01/01/1921
Event Type  Injury  
Event Description
It was reported that during surgery, when attempting to plug in sureshot distal targeter during the case, the instrument kept giving a "broken instrument" error. A backup drill guide was used but it gave the same error. It appears to be a problem with the port where the drill guide gets plugged in. Procedure was concluded using x-rays to insert distal screws and without delays.
 
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Brand NameTRAUMA INTERFACE
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
MDR Report Key10607764
MDR Text Key209209898
Report Number1020279-2020-04974
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K170280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71692802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
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 Initial

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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