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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 Calibration Problem (2890)
Patient Problem Injury (2348)
Event Date 04/03/2017
Event Type  Injury  
Manufacturer Narrative
The associated trauma interface was returned for evaluation and the sureshot targeter was not returned. Our investigation included an analysis from the manufacturer which indicated no hardware problem found on the interface. All functional tests were performed and it was noted the device functions as intended. A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes. A review of complaint history revealed no prior complaints for the same failure on the listed batch. A clinical evaluation noted that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation. A final operative x-ray was provided, which confirms that the screw is not inside the distal locking hole of the nail. The other distal screw does appear to be through the nail so only one is currently in the distal nail. Since no patient harm or injury is being reported at this time as a result of the extended surgery time and the procedure was completed, no further clinical assessment is warranted. No further actions are being taken at this time; however we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed. Should additional information be received, the complaint will be reopened.
 
Event Description
It was reported that one of the screws inserted on the patient's bone missed the nail hole and was not attached to the nail.
 
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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 Key7262345
MDR Text Key271655466
Report Number1020279-2018-00143
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
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 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2018
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2018
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 Reuse

Patient Treatment Data
Date Received: 02/10/2018 Patient Sequence Number: 1
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