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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT HUMERAL DRILL GUIDE PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. SURESHOT HUMERAL DRILL GUIDE PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 71691152
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 11/14/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, while drilling the distal screw using a sureshot, it was found the hole was out of alignment. They believe guide probe was set at "20" but it actually wasn't. It was loosed. Even when they tried to set "20" again, it did not work. Delay form, (0-30) minutes reported. Backup device available. No injury or impact to patient reported.
 
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Brand NameSURESHOT HUMERAL DRILL GUIDE PROBE
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 Key9443678
MDR Text Key170306490
Report Number1020279-2019-04343
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K110240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71691152
Device Catalogue Number71691152
Device Lot Number18GK00016
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 Received07/21/2020
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

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