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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 Not Applicable (3189)
Event Date 01/11/2018
Event Type  Injury  
Manufacturer Narrative
The associated trauma interface was not returned for evaluation. A photo was provided, however the stated failure could not be confirmed due to the poor quality of the picture. A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number. Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes. A clinical evaluation indicated that no patient injury was sustained as a result of this device related incident aside from the extended surgery time, and the procedure was completed using free-hand to insert distal screws. No further medical assessment is warranted based on the information provided. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary. We consider this investigation closed. Should the device or additional information be received, the complaint will be reopened.
 
Event Description
It was reported that during a meta tibia fixation surgery, surgeon experienced issues with the device, extending the surgical time for more than 30 minutes. No further impact on the patient.
 
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Brand NameTRAUMA INTERFACE
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 Key7227055
MDR Text Key111463697
Report Number1020279-2018-00075
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K170280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
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 Received01/14/2018
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

Patient Treatment Data
Date Received: 01/30/2018 Patient Sequence Number: 1
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