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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT DRILL SLEEVE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT DRILL SLEEVE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 71692805
Device Problem Defective Component (2292)
Patient Problem Injury (2348)
Event Date 02/27/2019
Event Type  Injury  
Event Description
It was reported that when trying to target the medial and lateral holes, doctor was off by a couple of mm posteriorly, but he managed to get one screw in by over compensating and was too far posteriorly from the second hole and hit the nail. No information about a delay was provided and back-up device was available but the procedure was completed using a freehand technique.
 
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Brand Name4.0MM SURESHOT SHORT DRILL SLEEVE
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
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8444329
MDR Text Key139576398
Report Number1020279-2019-01148
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71692805
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 Received02/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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